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N E U R O L O G I C A L C L I N I C A L R E S E A R C H I N S T I T U T E @ M G H

JUNE 1, 2016

Standard Library Forms

5 0 ST A N I F O R D ST R E E T , SU I T E 4 0 1 , B O S T O N, M A 0 2 1 1 4

As of June 1, 2016

Page 2 ©2016 Neurological Clinical Research Institute @ MGH

Table of Contents

1 GENERAL FORMS ........................................................................................................................5

12 Lead ECG .............................................................................................................................................. 5

Ashworth Spasticity Scale ......................................................................................................................... 7

Assistive Devices Log ................................................................................................................................. 9

ATLIS ........................................................................................................................................................ 13

BMI/Height and Weight .......................................................................................................................... 16

Bulbar Function VAS (Visual Analog Scale) ............................................................................................. 18

Clinical Research Participation Log ......................................................................................................... 20

CNS Lability Scale .................................................................................................................................... 21

Council of Nutrition appetite questionnaire (CNAQ) .............................................................................. 24

.................................................................................................................... 27

Demographics ......................................................................................................................................... 29

Diagnosis ................................................................................................................................................. 30

Diaphragm Pacing System Device ........................................................................................................... 31

Dietary Recall Questionnaire .................................................................................................................. 32

Dietary Recall Food Questionnaire ......................................................................................................... 40

Dietary Recall Questionnaire for All Patients ......................................................................................... 46

Fall Log .................................................................................................................................................... 48

Family History Log ................................................................................................................................... 50

Feeding Log ............................................................................................................................................. 54

Feeding Tube Placement ......................................................................................................................... 56

Grip Strength Testing .............................................................................................................................. 58

Hospitalization Log .................................................................................................................................. 59

Lipid Panel ............................................................................................................................................... 61

Medical History ....................................................................................................................................... 62

Medications Log ...................................................................................................................................... 64

MGH-SST (Swallow Screening Tool) ........................................................................................................ 68

Mortality ................................................................................................................................................. 70

MRC Grading ........................................................................................................................................... 72

Multidisciplinary Visit Summary ............................................................................................................. 76

Neurological Examination ....................................................................................................................... 78

As of June 1, 2016


Non-Invasive Ventilation Log .................................................................................................................. 83

Observed Salivation ................................................................................................................................ 85

Patient Education .................................................................................................................................... 87

Permanent Assisted Ventilation (PAV) ................................................................................................... 89

PET Scan .................................................................................................................................................. 90

Physical Examination .............................................................................................................................. 91

Post LP Phone Call ................................................................................................................................... 93

Pregnancy................................................................................................................................................ 94

PROMIS SF v1.1 ....................................................................................................................................... 96

Pulmonary Function Tests ..................................................................................................................... 100

Reflexes ................................................................................................................................................. 105

Safety Labs- Chemistry .......................................................................................................................... 108

Safety Labs- Hematology ...................................................................................................................... 110

Safety Labs-Urinalysis ........................................................................................................................... 112

Safety Labs-Pregnancy Test .................................................................................................................. 114

Sample Collection-Cerebrospinal Fluid (CSF) Sample ........................................................................... 116

Sample Collection-DNA Sample Collection ........................................................................................... 119

Sample Collection - DNA Sample Collection ......................................................................................... 120

Sample Collection-Inflammatory Markers Collection ........................................................................... 122

Sample Collection-PBMC Sample Collection ......................................................................................... 123

Sample Collection-Plasma Sample ........................................................................................................ 124

Sample Collection-RNA Sample Collection ........................................................................................... 127

Sample Collection-Sample Collection Questionnaire ........................................................................... 128

Sample Collection-Serum Sample ......................................................................................................... 129

Sample Collection-Urine Sample .......................................................................................................... 132

Sample Collection - Urine Sample Collection ........................................................................................ 133

Sample Collection-Whole Blood Sample .............................................................................................. 135

Skin Biopsy Procedure ........................................................................................................................... 136

Slow Vital Capacity ................................................................................................................................ 137

Southern Blot Analysis .......................................................................................................................... 139

Subject Final Disposition ....................................................................................................................... 140

Timed Reading of Test Paragraph ......................................................................................................... 142

As of June 1, 2016


Timed Swallowing Solids Test ............................................................................................................... 144

Timed Swallowing Water Test .............................................................................................................. 146

Tracheostomy ....................................................................................................................................... 149

TSPO Affinity Test.................................................................................................................................. 150

Ulcerative Colitis Activity Index (SCCAI) ................................................................................................ 151

Vital Capacity ........................................................................................................................................ 153

Vital Signs .............................................................................................................................................. 156

Weight History ...................................................................................................................................... 158

Wexner Constipation Scoring System ................................................................................................... 160

2 ALS FORMS ............................................................................................................................. 163

ALS CBS (Cognitive Behavioral Screen) ALS Caregiver Behavioral ........................................................ 163

ALS CBS (Cognitive Behavioral Screen) ................................................................................................. 167

ALS Diagnosis ........................................................................................................................................ 171

ALS Gene Mutations ............................................................................................................................. 173

ALS History ............................................................................................................................................ 175

ALSFRS-R ............................................................................................................................................... 177

ALS-Specific QoL Questionnaire Revised ........................................................................................... 183

Referral Information ............................................................................................................................. 201

UMN Registry Labs ................................................................................................................................ 202

3 ........................................................................ 203

4 SELECTION FORM ................................................................................................................... 204

As of June 1, 2016


1 GENERAL FORMS

12 Lead ECG [LIBRARY v1.2] [EDC VERSION 7]

Status Collected Not Collected

Reason not collected [TEXT]

Date Performed [DATE CONTROL]

[TEXT]

12-Lead ECG Measurements

Heart Rate PR Interval QRS Duration

QT Interval QTc Interval P Axis P-R-T Axes R Axis

T Axis

[NUMERIC] [NUMERIC] [NUMERIC] [NUMERIC] [NUMERIC] [NUMERIC] [NUMERIC]

12-Lead ECG

Abnormal

ECG Normal

Clinically Significant

Not Clinically Significant

Comments [TEXT]

If abnormal, check all that apply:

1 = Sinus bradycardia 8 = Premature atrial complexes 15 = Left axis deviation

2 = Sinus tachycardia 9 = Premature ventricular

complexes

16 = Left atrial enlargement

3 = Sick sinus syndrome 10 = Ventricular tachycardia 17 = Left ventricular

hypertrophy

4 = Atrial flutter 11 = Ventricular fibrillation 18 = Infarction

5 = Atrial fibrillation 12 = Prolonged PR interval / Heart

block

19 = Nonspecific STTWA

6 = Atrial tachycardia 13 = STTWA suggestive of ischemia 99 = Other

[TEXT] 7 = Marked sinus pauses 14 = Bundle branch block

As of June 1, 2016


Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

Return to Table of Contents

As of June 1, 2016


Ashworth Spasticity Scale [LIBRARY v1.2] [EDC VERSION 7]



Date performed: [DATE CONTROL]

[TEXT]

Key:

1. No increase in muscle tone.

is moved in flexion or extension

3. More marked increase in tone, but affected part is easily flexed.

4. Considerable increase in tone; passive movement difficult.

5. Affected part is rigid in flexion or extension

6. Not tested

7. Not tested (subject unable to perform task)

Ashworth Spasticity Scale

Limb

1

2

3

SCORE

4

5

6

7

Right Arm

Left Arm

Right Leg

Left Leg

Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016



As of June 1, 2016


Assistive Devices Log [LIBRARY v1.2] [EDC VERSION 7]

Mobili

ty

Orthos

es

NI

V

Communicati

on

Device

Other

respirato

ry

devices

Communicati

on Device

NIV

Usag

e

Date

recommend

ed

Dat

e

first

use

d

Date

discontinu

ed

***When adding a line***

Mobility

o Walking unassisted o Bracing/splints o Cane o Walker o Manual wheelchair o Power scooter o Power wheelchair o Other mobility device [TEXT]

Orthoses

o Inserts of any type o Supramalleolar orthotic (SMO) o Ankle-foot orthosis (AFO) o Knee-ankle-foot orthosis (KAFO) o Hip-knee-ankle orthosis (HKAFO) o Stander o Body jacket/corset/Thoracic-lumbar-sacral orthoses (TLSO) o Reciprocal gait orthoses (RGO) o Other orthoses [TEXT]

Non-invasive ventilation

o CPAP o BIPAP o BIPAP/AVAPS (Average Assured Pressure Support) o Trilogy NIV o Other NIV [TEXT]

Add Line Remove Line

As of June 1, 2016


Other respiratory devices

o Mechanical In-Exsuffulator (Cough-assist machine) o Diaphragm pacing o High Frequency Chest Wall Oscillation System (Percussion Vest) o Nebulizer o Suction o Tracheostomy o Trilogy TIV o Other TIV [TEXT]

_____________________________________________________________

Communication Device

o Call chime o Eye Gaze o Poster board o Speech generator device o Voice amplifier o Other Communication Device [TEXT]

_____________________________________________________________

Other

o Other [TEXT] ____________________________________________________________

NIV Usage

Single [NUMERIC] hours/day

Range [NUMERIC] [NUMERIC] hours/day

Date of physician recommendation [DATE CONTROL]

Date device FIRST used [DATE CONTROL]

Date device discontinued [DATE CONTROL]

Device brand and/or model [TEXT]

Other comments [TEXT]

As of June 1, 2016


As of June 1, 2016


ATLIS [LIBRARY v1.2] [EDC VERSION 7]

Status: Collected Not Collected Reason not collected [TEXT]

[TEXT] Date Performed: [DATE CONTROL] ATLIS MUSCLE TESTING

Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

Muscle Group Best Value(pounds) If Not Tested, please explain

LEFT GRIP

[NUMERIC]

Subject unable to perform task due to weakness Other (Specify): [TEXT]

RIGHT GRIP

[NUMERIC]


LEFT ELBOW FLEXION

[NUMERIC]


RIGHT ELBOW FLEXION

[NUMERIC]


LEFT ELBOW EXTENSION

[NUMERIC]


RIGHT ELBOW EXTENSION

[NUMERIC]


LEFT ANKLE DORSIFLEXION

[NUMERIC]


RIGHT ANKLE DORSIFLEXION

[NUMERIC]


LEFT KNEE EXTENSION

[NUMERIC]


RIGHT KNEE EXTENSION

[NUMERIC]


LEFT KNEE FLEXION

[NUMERIC]


RIGHT KNEE FLEXION

[NUMERIC]


As of June 1, 2016


As of June 1, 2016


BMI/Height and Weight [NEW LIBRARY] [EDC VERSION 7]

Status: Collected Not Collected

Reason not collected: [TEXT]

Date Performed: [DATE]

[TEXT]

BMI, Height and Weight

Test Measurement Unit

Weight [NUMERIC] lb

kg

Height [NUMERIC] in

cm

BMI [NUMERIC]

As of June 1, 2016



As of June 1, 2016


Bulbar Function VAS (Visual Analog Scale) [LIBRARY v1.2] [EDC VERSION 7]



Date Performed: [DATE CONTROL]

[TEXT]

Function 1 2 3 4 5 6 7 8 9 10

Speech

Swallowing

Sialorrhea

Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016



As of June 1, 2016


Clinical Research Participation Log [LIBRARY 1.0] [EDC VERSION 7]

Name of

Clinical Study:

Patient ID in

Clinical Study

Remove Line

Add Line


Name of Clinical Study: [TEXT]

Patient ID in Study: [DATE CONTROL]

(if known)

If patient received an investigational drug as part of the trial, please add an entry to the Medication Log.


As of June 1, 2016


CNS Lability Scale [LIBRARY v1.1] [EDC VERSION 7]




Form Completed by: Patient Person other than patient

[TEXT]

Please select the number that describes the degree to which each item has applied to

you DURING THE PAST WEEK.

Does not

apply

1

Rarely

Applies

2

Occasionally

Applies

3

Frequently

Applies

4

Applies Most of

the Time

5

1. There are times

when I feel fine 1

become tearful the

next over something

small or for no reason

at all.

2. Others have told

me that I seem to

become amused very

easily or that I seem to

become amused about

funny.

3. I find myself crying

very easily.

4. I find that even

when I try to control

my laughter, I am

often unable to do so.

As of June 1, 2016


5. There are times

thinking of anything

happy or funny at all,

be overcome by funny

or happy thoughts.

6. I find that even

when I try to control

my crying, I am often

unable to do so.

7. I find that I am

easily overcome by

laughter.

TOTAL: [CALCULATED]

Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016



As of June 1, 2016


Council of Nutrition appetite questionnaire (CNAQ) [LIBRARY 1.0] [EDC VERSION 7]


QUESTION RESPONSE

My appetite is Very poor Poor Average Good Very good

When I eat I feel full after eating only a few mouthfuls I feel full after eating about a third of a meal I feel full after eating over half a meal I feel full after eating most of the meal I hardly ever feel full

I feel hungry Rarely Occasionally Some of the time Most of the time All of the time

Food tastes Very bad Bad Average Good Very good

Compared to when I was younger, food tastes

Much worse Worse Just as good Better Much better

Normally I eat Less than one meal a day One meal a day Two meals a day Three meals a day More than three meals a day

I feel sick or nauseated when I eat

Most times Often Rarely Never

Most of the time my mood is Very sad Sad Neither sad nor happy Happy Very happy

As of June 1, 2016


Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016



As of June 1, 2016


Index (HBI) [LIBRARY v1.0] [EDC VERSION 7]

Status: Collected Not Collected Reason not collected: [TEXT] Date Performed: [DATE CONTROL] 1. How would you describe your general well being over the past week?

Generally well Slightly below par Poor Very poor Terrible

2. On average, over the past week, would you rate your abdominal pain as:

None Mild Moderate Severe

3. On average, in the past week, how many liquid or very soft stools have you had per day? [NUMERIC] 4. Have you had any complications? (Check one or more):

Arthralgia Uveitis Erythema nodosum Pyoderma gangrenosum New Fistula Abscess Apthous ulcers None

As of June 1, 2016



As of June 1, 2016


Demographics [LIBRARY v1.3] [EDC VERSION 7]

Date of Birth: [DATE CONTROL]

Age: [NUMERIC]

Sex: Male Female

The patient identifies himself/herself as being:

Ethnic category: Hispanic or Latino Not Hispanic or Latino

Racial categories: White

Black/African American

Asian

Native Hawaiian/Pacific Islander

American Indian/Alaska Native


As of June 1, 2016


Diagnosis [LIBRARY 1.1] [EDC VERSION 7]

Date of Diagnosis: [DATE CONTROL]

ALS Phenotype

o UMN = LMN o Upper motor neuron predominant (UMND) o Lower motor neuron predominant (LMND) o Progressive bulbar palsy (PBP) o Primary lateral sclerosis (PLS) (UMN only) o Progressive muscular atrophy (PMA) (LMN Only)

Clinical Data Source:

Investigator/submitter

Primary care physician

Medical record

Neurologist (other than study investigator)


As of June 1, 2016


Diaphragm Pacing System Device [LIBRARY v1.1] [EDC VERSION 7]

Date Recommended: [DATE CONTROL]

Admission Date: [DATE CONTROL]

Date of Placement: [DATE CONTROL]

Discharge Date: [DATE CONTROL]


As of June 1, 2016


Dietary Recall Questionnaire [NEW LIBRARY]

Status Collected Not Collected Reason not collected: [TEXT] Date Performed: [DATE CONTROL]

1) In the past 2 weeks, please check if you have received any of the following medications as pills or through the vein (DO NOT INCLUDE INHALERS):

Antibiotics

Chemotherapy

Immunosuppressants (e.g. oral corticosteroids)

2) In the past 2 weeks, have you undergone a colonoscopy or other procedure requiring bowel preparation?

Yes No

3) In the past 2 weeks, have you used an oral contrast agent for a CT scan or x-ray?

Yes No

4) In the past 2 weeks, have you had diarrhea?

Yes No

5) In the past 2 weeks, have you been hospitalized for any reason?

Yes No

6) Have you ever had bowel surgery?

Yes No

As of June 1, 2016


Did you eat or drink the following products in the last 7 days?

Tea or coffee no sugar and no sugar

replacement

No, I did not consume these products in the last 7 days Within the past 4 to 7 days Within the past 2 to 3 days Yesterday, 1 to 2 times Yesterday, 3 or more times

Soft drinks, tea or coffee with sugar (corn

syrup, maple syrup, cane sugar, etc.)


Diet soft drinks, tea or coffee with sugar

substitute (Stevia, Equal, Splenda, etc.)


Fruit juice (orange, apple, cranberry,

prune, etc.)


Water


Alcohol (beer, brandy, spirits, hard liquor,

wine, aperitif, etc.)


Yogurt or other foods containing active

bacterial cultures (kefir, sauerkraut, etc.)


As of June 1, 2016


Dairy (milk, cream, ice cream, cheese,

cream cheese)


Probiotic (other than yogurt)


Fruits (no juice) (Apples, raisins, bananas,

oranges, strawberries, blueberries, etc.

(frozen or fresh)


Vegetables (salad, tomatoes, onions,

greens, carrots, peppers, green beans,

etc.)


Beans (tofu, soy, soy burgers, lentils,

Mexican beans, lima beans, etc.)


Whole grains (wheat, oats, brown rice,

rye, quinoa, wheat bread, wheat pasta,

etc.)


Starch (white rice, bread, pizza, potatoes,

yam, cereals, pancakes, etc.)


Eggs


Processed meat (other red meat and other

white meat such as lunch meat, ham,

salami, bologna, sausage, kielbasa, hotdog,

bacon, etc.)


As of June 1, 2016


Red meat (beef, hamburger, pork, lamb)


White meat (chicken, turkey, etc.)


Shellfish (shrimp, lobster scallops, etc.)


Fish (fish nuggets, breaded fish, fish cakes,

salmon, tuna, etc.)


Sweets (pies, jam, chocolate, cake,

cookies, etc.)


As of June 1, 2016


As of June 1, 2016


Dietary Recall Food Questionnaire [LIBRARY v1.0] [EDC VERSION 7]




Dietary Recall Food Questionnaire Table

Did you eat or drink the following products in the last 7 days?

Tea or coffee no sugar and no sugar

replacement


Soft drinks, tea or coffee with sugar (corn

syrup, maple syrup, cane sugar, etc.)


Diet soft drinks, tea or coffee with sugar

substitute (Stevia, Equal, Splenda, etc.)


Fruit juice (orange, apple, cranberry,

prune, etc.)


Water


Alcohol (beer, brandy, spirits, hard liquor,

wine, aperitif, etc.)


Yogurt or other foods containing active

bacterial cultures (kefir, sauerkraut, etc.)


As of June 1, 2016


Dairy (milk, cream, ice cream, cheese,

cream cheese)


Probiotic (other than yogurt)


Fruits (no juice) (Apples, raisins, bananas,

oranges, strawberries, blueberries, etc.

(frozen or fresh)


Vegetables (salad, tomatoes, onions,

greens, carrots, peppers, green beans,

etc.)


Beans (tofu, soy, soy burgers, lentils,

Mexican beans, lima beans, etc.)


Whole grains (wheat, oats, brown rice,

rye, quinoa, wheat bread, wheat pasta,

etc.)


Starch (white rice, bread, pizza, potatoes,

yam, cereals, pancakes, etc.)


Eggs


Processed meat (other red meat and other

white meat such as lunch meat, ham,

salami, bologna, sausage, kielbasa, hotdog,

bacon, etc.)


As of June 1, 2016


Red meat (beef, hamburger, pork, lamb)


White meat (chicken, turkey, etc.)


Shellfish (shrimp, lobster scallops, etc.)


Fish (fish nuggets, breaded fish, fish cakes,

salmon, tuna, etc.)


Sweets (pies, jam, chocolate, cake,

cookies, etc.)


As of June 1, 2016


As of June 1, 2016


Dietary Recall Questionnaire for All Patients [NEW LIBRARY]




6) In the past 2 weeks, please check if you have received any of the following medications as pills or through the vein (DO NOT INCLUDE INHALERS):

Antibiotics

Chemotherapy

Immunosuppressants (e.g oral corticosteroids)

7) In the past 2 weeks, have you undergone a colonoscopy or other procedure requiring bowel preparation?

Yes No

8) In the past 2 weeks, have you used an oral contrast agent for a CT scan or x-ray?

Yes No

9) In the past 2 weeks, have you had diarrhea?

Yes No

10) In the past 2 weeks, have you been hospitalized for any reason?

Yes No

6) Have you ever had bowel surgery?

Yes No

As of June 1, 2016



As of June 1, 2016


Fall Log [LIBRARY v1.2] [EDC VERSION 7]

Date of last visit Date of current visit Fall type Near Fall count Fall count Fall reporting type


Date of last visit [DATE CONTROL]

Date of current visit [DATE CONTROL]

During this time period, the subject experienced

o No events o Near Fall(s) o Fall(s) o Both (falls and near falls)

Number of Near Fall events experienced: [NUMERIC]

Number of Fall events experienced: [NUMERIC]

Falls were reported Verbally Documented


As of June 1, 2016



As of June 1, 2016


Family History Log [LIBRARY v1.2] [EDC VERSION 7]

Relative Heredity Gender GUID of selected

relative

Please select all mutations

for which family member

has tested positive


Relative

Mother Father Sister Brother Half-sister Half-brother Daughter Son Grandmother Grandfather Aunt Uncle Cousin Other relative [TEXT]

Heredity Paternal Maternal

Gender Male Female

GUID of Relative: [TEXT]


As of June 1, 2016


Please select all medical conditions affecting selected family member

Amyotrophic Lateral Sclerosis Dementia Frontotemporal Dementia Psychiatric Disorder: [TEXT] Arthritis Asthma Cancer Circulation Problems Diabetes Heart Disease High Blood Pressure Lung Disease Stroke Other Disease [TEXT]

Genetic testing performed Yes No

Please select all mutations for which family member has tested positive

ANG C9ORF72 FUS Progranulin SETX SOD1 TAU TDP-43 VAPB VCP Other: [TEXT]

As of June 1, 2016


As of June 1, 2016


Feeding Log [LIBRARY 1.1] [EDC VERSION 7]

Type Other Type Frequency Formula Calories/feeding Start date Stop Date

Feeding Log

Bolus G-tube

Feeding Type Continuous G-tube

Oral liquid supplement intake

Other, specify [TEXT]

Feeding frequency [NUMERIC] times/day

Formula name (generic or trade name) [TEXT]

Calorie intake per feeding [NUMERIC] Cal/feeding

Feeding schedule start date [DATE CONTROL] (mm/dd/yyyy)

Feeding schedule stop date [DATE CONTROL] (mm/dd/yyyy)

Remove Line Add Line

As of June 1, 2016



As of June 1, 2016


Feeding Tube Placement [LIBRARY v1.1] [EDC VERSION 7]

Date recommended [DATE CONTROL]

Date accepted [DATE CONTROL]

Admission date: [DATE COTNROL]

Discharge date: [DATE CONTROL]

Type of feeding tube Nasogastric Gastrostomy

Placement method

o General surgery o Interventional Radiology o Microscopic Laparotomy o Percutaneous Endoscopic Gastrostomy o Other, specify: [TEXT]

Feeding tube placement was: Prophylactic/elective Emergent

Morbidity/mortality related to feeding tube:

Aspiration Death (Please complete Mortality form) Excessive Pain Hemorrhage Local infection Nausea/vomiting Oxygen desaturation/inadequate ventilation during procedure Peritonitis Procedure aborted secondary to anatomy Other, specify: [TEXT]

Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016



As of June 1, 2016


Grip Strength Testing [LIBRARY v1.0] [EDC VERSION 7]

Status: Done Not Done


[TEXT]

GRIP STRENGTH TESTING

Not Tested Trial 1 (pounds) Trial 2 (pounds) explain

LEFT GRIP STRENGTH

Left Grip Strength

Setting: [NUMERIC]

[NUMERIC] [NUMERIC]

Subject unable to

perform task due to

weakness

Other (Specify):

[TEXT]

RIGHT GRIP

STRENGTH

Right Grip Strength

Setting: [NUMERIC]

[NUMERIC] [NUMERIC]

Subject unable to

perform task due to

weakness

Other (Specify):[TEXT]


As of June 1, 2016


Hospitalization Log [LIBRARY v1.1] [EDC VERSION 7]

Reason Admission Date Discharge Date Ventilated

*When adding a line

Reason [TEXT]

Admission date: [DATE CONTROL]

Discharge date [DATE CONTROL]

Was patient ventilated Yes No


As of June 1, 2016



As of June 1, 2016


Lipid Panel [LIBRARY 1.0] [EDC VERSION 7]



Date Drawn: [DATE CONTROL]


Lipid Panel

Type Units Results Normal Abnormal and Not


Abnormal and

Clinically

Significant

Total Cholesterol [TEXT] [TEXT]

HDL Cholesterol [TEXT] [TEXT]

Triglycerides [TEXT] [TEXT]

LDL Cholesterol [TEXT] [TEXT]

VLDL Cholesterol [TEXT] [TEXT]

LDL/HDL Ratio Ratio [TEXT]

As of June 1, 2016


Medical History [LIBRARY v1.3] [EDC VERSION 7]

Description

Year of Diagnosis Still Present


Please enter any medical history the patient may have from any of the following body systems:

Allergies, Cardiovascular, Dermatologic, Endocrine and Metabolic, Gastrointestinal and Hepatic, HEENT,

Hematologic and Lymphatic, Immune and Inflammatory, Musculoskeletal, Neurologic (other than ALS),

Psychiatric, Respiratory, Urinary and Reproductive

Description [TEXT]

Year of Diagnosis [DATE CONTROL]

Still Present Yes No


As of June 1, 2016



As of June 1, 2016


Medications Log [LIBRARY v1.2] [EDC VERSION 7]

Medication Dose Unit Route Frequency Investigational

Drug Indication

Start

Date

Stop

Date Note


Medication/Supplement [TEXT]

Dose [TEXT]

Unit

micrograms (ucg) milligrams (mg) grams (g) tablet (s) capsule (s) gtt milliequivalent (meq) international units (IU) units (U) other (please specify): [TEXT]

Route

oral intravenous subcutaneous topical inhalation transdermal rectal intramuscular sublingual PEG other (please specify): [TEXT]


As of June 1, 2016


Frequency

QD BID TID QID QHS continuous IV PRN other (please specify): [TEXT]

Investigational Drug Yes No

Indication [TEXT]

Start Date [DATE CONTROL]

Stop Date [DATE CONTROL]

Note [TEXT]

As of June 1, 2016


As of June 1, 2016


MGH-SST (Swallow Screening Tool) [LIBRARY 1.0] [EDC VERSION 7]

Status: Completed Not Completed

Part One:

Awake Upright Stable Breathing Clean Oral Cavity

PASS - If ALL FOUR are present, proceed to PART TWO.

FAIL - If ANY ITEM is absent, STOP. Maintain NPO. Re-screen when able.

Part Two:

Present

Absent Clinical-Features Target

Tongue Movement Stick tongue straight out and lick all the way

around lips fully touching both sides

Cough Produce a strong, sharp cough

Voice Quality Phonate loudly and clearly; without

hoarse, breathy or wet quality

Pharyngeal

Sensation

Identify when each side of pharynx is touched

with the cotton-tipped swab

Water Drinking Drink 3 single teaspoons of water without

cough, throat clearing, or change in voice. If

none present, drink 1/2 cup of water without

cough, throat clearing or change in

voice/breathing

SCORE: [AUTO-CALCULATED] (6 MAXIMUM)

As of June 1, 2016



As of June 1, 2016


Mortality [LIBRARY B 1.0] [EDC VERSION 7]

Date of death: [DATE CONTROL]

Cause of death: [TEXT]

ICD-10 CM Code for cause of death: [TEXT]

Was an autopsy performed? Yes No Unknown

Complete autopsy

Limited autopsy (brain and spinal cord only)

[NUMERIC] hrs

[DATE CONTROL]

topsy [TEXT]

Has a copy of the report been obtained? Yes No

Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016



As of June 1, 2016


MRC Grading [LIBRARY 1.1] [EDC VERSION 7]



Date administered [DATE CONTROL]

[TEXT]

Score (Left)

Test Area 0 0+ / 1- 1 1+ / 2- 2 2+ / 3- 3 3+ / 4- 4 4+ / 5- 5

Shoulder

Abduction

Shoulder

Flexion

Shoulder

Extension

Shoulder

Internal

Rotation

Elbow

Flexion

Elbow

Extension

Wrist

Flexion

Wrist

Extension

Finger

Abduction

Thumb

Abduction

Hip Flexion

As of June 1, 2016


Hip

Extension

Hip

Abduction

Hip

Adduction

Knee

Extension

Knee Flexion

Ankle Dorsal

Flexion

Ankle

Plantar

Flexion

Score (Right)

Test Area 0 0+ / 1- 1 1+ / 2- 2 2+ / 3- 3 3+ / 4- 4 4+ / 5- 5

Shoulder

Abduction

Shoulder

Flexion

Shoulder

Extension

Shoulder

Internal

Rotation

Elbow

Flexion

Elbow

Extension

Wrist

Flexion

As of June 1, 2016


Wrist

Extension

Finger

Abduction

Thumb

Abduction

Hip Flexion

Hip

Extension

Hip

Abduction

Hip

Adduction

Knee

Extension

Knee Flexion

Ankle Dorsal

Flexion

Ankle

Plantar

Flexion

Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016



As of June 1, 2016


Multidisciplinary Visit Summary [LIBRARY 1.1] [EDC VERSION 7]

Visit Summary

Specialist Seen Referred

Dietician/nutritionist

Durable medical equipment vendor

Genetic counselor

Geneticist

Neurologist

Neuropsychologist

Nurse practitioner

Occupational therapist

Orthotic expert

Palliative care specialist

Patient advocacy representative

Physiatrist/PMR

Physical therapist

Physician assistant

Psychologist

Pulmonologist

Research coordinator

Respiratory therapist

Seating specialist

Social worker

Speech language pathologist

Other: [TEXT]

As of June 1, 2016



As of June 1, 2016


Neurological Examination [LIBRARY v1.1] [EDC VERSION 7]



Date of Exam: [DATE CONTROL]

[TEXT]

GENERAL: Normal Abnormal Not Done Comments

Level of Consciousness [TEXT]

Level of

Appearance/Facial/Motor

Expression

[TEXT]

Mental Status [TEXT]

Language [TEXT]

CRANIAL NERVES: Normal Abnormal Not Done Comments

Vision (II) [TEXT]

Eye Movements (III, IV, VI) [TEXT]

Jaw movement and facial

sensation (V) [TEXT]

Facial motion (VII) [TEXT]

Hearing (VIII) [TEXT]

Swallowing, pharynx, larynx

(IX, X) [TEXT]

SCM, trapezius (XI) [TEXT]

Tongue (XII) [TEXT]

As of June 1, 2016


Plantar Down Up Mute Not Done Comments

Left foot [TEXT]

Right foot [TEXT]

MOTOR SYSTEM : Normal Abnormal Not Done Comments

General Movement [TEXT]

Muscle Bulk/Mass [TEXT]

Muscle Strength:

Trunk [TEXT

Left Upper Extremity [TEXT]

Right Upper Extremity [TEXT]

Left Lower Extremity [TEXT]

Right Lower Extremity [TEXT]

Muscle Tone:

Left Upper Extremity [TEXT]

Right Upper Extremity [TEXT]

Left Lower Extremity [TEXT]

Right Lower Extremity [TEXT]

COORDINATION /

CEREBELLAR FUNCTON Normal Abnormal Not Done Comments

Gait [TEXT]

Nystagmus [TEXT]

Finger-Nose [TEXT]

As of June 1, 2016


SENSATION : Normal Abnormal Not Done Comments

Upper Extremities

Pain/Temperature [TEXT]

Light Touch [TEXT]

Position [TEXT]

Vibration [TEXT]

Lower Extremities

Pain / Temperature [TEXT]

Light Touch [TEXT]

Position [TEXT]

Vibration [TEXT]

Reflexes

Jaw reflexes Absent Normal Brisk

Not

Done Left 0 1+ 2+ 3+ 4+

Not

Done

Right 0 1+ 2+ 3+ 4+

Pectoral Pectoral

Biceps Biceps

Brachioradials Brachioradials

Triceps Triceps

Knee Knee

Ankle Ankle

Plantar [DROP DOWN]

Plantar [DROP DOWN]

Abdominals [DROP DOWN]

Abdominals [DROP DOWN]

Hoffman sign [DROP DOWN] Hoffman sign [DROP DOWN]

As of June 1, 2016


Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016



As of June 1, 2016


Non-Invasive Ventilation Log [LIBRARY v1.1] [EDC VERSION 7]

Non-

Invasive

ventilatio

n type

NIV

Usage

NIV

hours/da

y

NIV

Usage NIV Range: Low

NIV Range:

High

Date

recomme

nded

NIV Start

Date

NIV Stop

Date


**When adding a line**

Type of NIV used

CPAP

BIPAP

BIPAP/AVAPS (Average Volume Assured Pressure Support)

Trilogy NIV

Other NIV [TEXT]

NIV Usage

Single [NUMERIC] hours/day

Range [NUMERIC] [NUMERIC] hours/day

Date recommended by physician [DATE CONTROL]

Start Date [DATE CONTROL]

Stop Date [DATE CONTROL]

Device brand and/or model [TEXT]

Comments [TEXT AREA]

As of June 1, 2016



As of June 1, 2016


Observed Salivation [LIBRARY v1.2] [EDC VERSION 7]




[TEXT]

OBSERVED SALIVATION

Symptom Finding Comments

Resting Drooling

Present Absent

[TEXT]

Resting Dabbing

Yes No

[TEXT]

Stimulated Drooling

Present Absent

[TEXT]

Stimulated Dabbing

Yes No

[TEXT]

Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016



As of June 1, 2016


Patient Education [LIBRARY 1.1] [EDC VERSION 7]




[TEXT]

Indicate all patient education items discussed during this visit

Comments

Advanced directives [TEXT]

Caregiver support [TEXT]

Emergency plan [TEXT]

Enteral education including PEG or RIG [TEXT]

Heimlich maneuver [TEXT]

Home safety [TEXT]

Hospice [TEXT]

Insurance/Social Security benefits [TEXT]

Living will [TEXT]

Mechanical ventilation [TEXT]

Medical POA [TEXT]

Multidisciplinary care plan [TEXT]

Research and clinical trial participation [TEXT]

Riluzole [TEXT]

Vaccinations [TEXT]

Other [TEXT] [TEXT]

As of June 1, 2016


Data Source

medical records

original collection

patient reported

unknown

other [TEXT]


As of June 1, 2016


Permanent Assisted Ventilation (PAV) [LIBRARY 1.1] [EDC VERSION 7]

Did the patient reach permanent assisted ventilation (PAV)? Yes No

[Date CONTROL]

Comments: [TEXT]


As of June 1, 2016


PET Scan [LIBRARY v1.0] [EDC VERSION 7]

Was the PET scan performed? Yes No

Accession Number: [TEXT]

Date: [DATE CONTROL]

Time of Injection: [NUMERIC] : [NUMERIC] (24hr clock)

Scan Start Time: [NUMERIC] : [NUMERIC] (24hr clock)

Scan Stop Time: [NUMERIC] : [NUMERIC] (24hr clock)

Was the scan interrupted? Yes No

If yes, specify reason: [TEXT]


As of June 1, 2016


Physical Examination [LIBRARY 1.2] [EDC VERSION 7]



Date of Exam: [DATE CONTROL]

[TEXT]

Physical Examination

Area Tested Normal Abnormal and

Not Clinically

Significant

Abnormal and

Clinically

Significant

Comments

General

appearance

[TEXT]

HEENT [TEXT]

Respiratory [TEXT]

Cardiovascular [TEXT]

Gastrointestinal [TEXT]

Genito-urinary [TEXT]

Neurological [TEXT]

Musculoskeletal [TEXT]

Lymph Nodes [TEXT]

Other [TEXT] [TEXT]

Other [TEXT] [TEXT]

Other [TEXT] [TEXT]

Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016



As of June 1, 2016


Post LP Phone Call [LIBRARY 1.1] [EDC VERSION 7]

Was the phone call completed? Yes No

If Yes, date of phone call: [DATE CONTROL] If No, reason: [TEXT]

Did the patient have any post-lumbar puncture adverse events?

Yes No

If Yes, please update the Adverse Event or Clinical Milestones log

If the patient had a post-lumbar puncture adverse event (i.e., headache), did the patient receive a

caffeine drip treatment?

Yes No

If the patient had a post-lumbar puncture adverse event (i.e., headache), did the patient receive a blood

patch? Yes No


As of June 1, 2016


Pregnancy [LIBRARY 1.1] [EDC VERSION 7]

Date Reported: [DATE CONTROL]

Start date of last menses: [DATE CONTROL]

Date pregnancy confirmed: [DATE CONTROL]

Anticipated date of childbirth: [DATE CONTROL]

Pregnancy History

0 1 2 3 4 5 6 >6

Number of

Pregnancies:

Number of

Normal

Deliveries:

Spontaneous

Miscarriage:

Other (please specify): [TEXT]

Pregnancy Outcome:

Not known at this date Still Birth Uneventful (normal/healthy baby) Neonatal death Induced Abortion Spontaneous Abortion Birth defects

Comments: [TEXT]

Date of outcome: [DATE]

Pregnancy Reported By (Study Staff Name): [TEXT]

As of June 1, 2016



As of June 1, 2016


PROMIS SF v1.1 [LIBRARY 1.0] [EDC VERSION 7]

Status: Completed Not Completed

Excellent Very good Good Fair Poor

In general,

would you say

your health is

In general,

would you say

your quality of

life is

In general, how

would you rate

your physical

health?

In general, how

would you rate

your mental

health,

including your

mood and your

ability to think?

In general, how

would you rate

your

satisfaction

with your social

activities and

relationships?

As of June 1, 2016


In general,

please rate how

well you carry

out your usual

social activities

and roles. (This

includes

activities at

home, at work

and in your

community,

and

responsibilities

as a parent,

child, spouse,

employee,

friend, etc.)

Completely Mostly Moderately A little Not at all

To what extent

are you able to

carry out your

everyday

physical

activities such

as walking,

climbing stairs,

carrying

groceries, or

moving a

chair?

As of June 1, 2016


In the past 7 days . . .

Never

Rarely

Sometimes

Often

Always

How often have you been

bothered by emotional

problems such as feeling

anxious, depressed or

irritable?

None Mild Moderate Severe Very severe

How would you

rate your fatigue on

average?

No

Pain

Worst Pain

Imaginable

How would you rate your pain on average?

As of June 1, 2016



As of June 1, 2016


Pulmonary Function Tests [LIBRARY 1.2] [EDC VERSION 7]




[TEXT: 4 Characters]

Forced Vital Capacity

Position Unknown Position Patient Liters Predicted % Predicted

Upright [NUMERIC] [NUMERIC] [CALCULATED]

%

Supine [NUMERIC] [NUMERIC] [CALCULATED]

%

Slow Vital Capacity



%


%

Maximum Inspiratory Pressure

Position Unknown Position Patient cm of H2O

Upright [NUMERIC]

Supine [NUMERIC]

Maximal Voluntary Ventilation


Upright [NUMERIC]

Supine [NUMERIC]

As of June 1, 2016


SNIP (Sniff Nasal Inspiratory Pressure)


Upright [NUMERIC]

Supine [NUMERIC]

Maximum Expiratory Pressure


Upright [NUMERIC]

Supine [NUMERIC]

Peak Inspiratory Flow Rate

Position Unknown Position Patient Liters / second

Upright [NUMERIC]

Supine [NUMERIC]

Peak Expiratory Flow Rate

Position Unknown Position Patient Liters / second

Upright [NUMERIC]

Supine [NUMERIC]

Forced Expiratory Volume In 1 Second (FEV1)



%


%

As of June 1, 2016


Forced Expiratory Volume In 6 Second (FEV6)



%


%

Single Breath Count

Position Unknown Position Count

Upright [NUMERIC]

Supine [NUMERIC]

Normal

Slightly Decreased

Sniff test (bedside) Very Weak or Nil

Inverted

Mask or mouth seal used? Yes No

Other pulmonary testing: Not recommended

Nocturnal oximetry

Polysomnogram

Other pulmonary test: [TEXT]

Data Source

medical records

original collection

patient reported

unknown

other [TEXT]

As of June 1, 2016


As of June 1, 2016


Reflexes [LIBRARY v1.0] [EDC VERSION 7]

Status Done Not Done


[TEXT]

Reflexes

Not

Done Cranial 0 1+

Jaw Jerk

Facial Reflex

Palmomental Sign

Not

Done Left Cervical 0 1+

Not

Done Right Cervical 0 1+

Triceps Reflex Triceps Reflex

Biceps Reflex Biceps Reflex

Finger Flexors Finger Flexors

Clonus Clonus

Not

Done Left Lumbosacral 0 1+

Not

Done Right Lumbosacral 0 1+

Patellar Reflex Patellar Reflex

Crossed Adduction Crossed Adduction

Ankle Reflex Ankle Reflex

Clonus Clonus

Babinski Sign Babinski Sign

As of June 1, 2016


As of June 1, 2016


Safety Labs- Chemistry [LIBRARY 1.2] [EDC VERSION 7]




CHEMISTRY



Abnormal and

Clinically

Significant

SGPT (ALT) [TEXT] [TEXT]

SGOT (AST) [TEXT] [TEXT]

Albumin [TEXT] [TEXT]

Alkaline Phosphatase [TEXT] [TEXT]

BUN [TEXT] [TEXT]

Calcium [TEXT] [TEXT]

Chloride [TEXT] [TEXT]

Creatinine [TEXT] [TEXT]

Glucose [TEXT] [TEXT]

Potassium [TEXT] [TEXT]

Sodium [TEXT] [TEXT]

Total Bilirubin [TEXT] [TEXT]

Total Protein [TEXT] [TEXT]

Other 1 : [TEXT] [TEXT] [TEXT]



As of June 1, 2016



As of June 1, 2016


Safety Labs- Hematology [LIBRARY 1.2] [EDC VERSION 7]




HEMATOLOGY



Abnormal and

Clinically

Significant

CBC (With Diff)

Hemoglobin [TEXT] [TEXT]

Hematocrit % [TEXT]

Total RBC [TEXT] [TEXT]

MCV [TEXT] [TEXT]

MCH [TEXT] [TEXT]

MCHC [TEXT] [TEXT]

Platelet count [TEXT] [TEXT]

Total WBC count [TEXT] [TEXT]

Neutrophils % [TEXT]

Lymphocytes % [TEXT]

Monocytes % [TEXT]

Eosinophils % [TEXT]

Basophils % [TEXT]




As of June 1, 2016



As of June 1, 2016


Safety Labs-Urinalysis [LIBRARY 1.2] [EDC VERSION 7]




URINALYSIS



Abnormal and

Clinically

Significant

Albumin [TEXT] [TEXT]

Bilirubin [TEXT] [TEXT]

Blood [TEXT] [TEXT]

Clarity [TEXT] [TEXT]

Color [TEXT] [TEXT]

Glucose [TEXT] [TEXT]

Ketones [TEXT] [TEXT]

Nitrites [TEXT] [TEXT]

PH [TEXT] [TEXT]

Protein [TEXT] [TEXT]

Specific Gravity [TEXT] [TEXT]

Urobilinogen [TEXT] [TEXT]

WBCs [TEXT] [TEXT]




As of June 1, 2016



As of June 1, 2016


Safety Labs-Pregnancy Test [LIBRARY 1.1] [EDC VERSION 7]




Test Type: Serum Urine

Typ Results

hCG

Positive

Negative

As of June 1, 2016



As of June 1, 2016


Sample Collection-Cerebrospinal Fluid (CSF) Sample [LIBRARY 1.4] [EDC VERSION 7]



Date CSF Sample Collected [DATE CONTROL]

[TEXT]

Collection number [NUMERIC]

Time Collected: [NUMERIC] :[NUMERIC] (24hr clock)

Pre-centrifugation

sample

appearance

Clear Pink Cloudy Other [TEXT]

Time started

centrifugation:

[NUMERIC] :[NUMERIC] (24hr clock)

Speed of

centrifugation:

[NUMERIC] x g (times gravity)

Duration of

centrifugation:

[NUMERIC] minutes

Post-

centrifugation

sample

appearance

Clear Pink Cloudy Other [TEXT]

Time aliquoted: [NUMERIC] :[NUMERIC] (24hr clock)

Time aliquots put

on dry ice:

[NUMERIC] :[NUMERIC] (24hr clock) N /A

Time aliquots put

in -70C or -80C

freezer:


As of June 1, 2016


Number of aliquots Aliquot volume Units Volume of last aliquot



Number of full aliquots [NUMERIC]

Volume of aliquots [NUMERIC] [DROPDOWN MENU: ml,

Volume of last aliquot if less than volume specified above [NUMERIC]

As of June 1, 2016



As of June 1, 2016


Sample Collection-DNA Sample Collection [LIBRARY 1.1] [EDC VERSION 7]



Date DNA Collected [DATE CONTROL]

[DATE CONTROL]


Number of DNA Tubes Collected [NUMERIC]


As of June 1, 2016


Sample Collection - DNA Sample Collection [LIBRARY B v1.0] [EDC VERSION 7]



Date DNA Collected [DATE CONTROL]

Initials [DATE CONTROL]


Number of DNA Tubes Collected [NUMERIC]






As of June 1, 2016



As of June 1, 2016


Sample Collection-Inflammatory Markers Collection [LIBRARY 1.0] [EDC VERSION 7]



Date collected: [DATE CONTROL]

[DATE CONTROL]


Number of tubes collected: [NUMERIC]

Date tubes shipped: [DATE CONTROL]


As of June 1, 2016


Sample Collection-PBMC Sample Collection [LIBRARY 1.0] [EDC VERSION 7]




[TEXT]


Number of tubes collected: [NUMERIC]

Date tubes shipped: [DATE CONTROL]


As of June 1, 2016


Sample Collection-Plasma Sample [LIBRARY 1.3] [EDC VERSION 7]




[DATE CONTROL]


As of June 1, 2016


Number of aliquots Aliquot volume Units Volume of last aliquot

***When adding a line

Number of full aliquots [NUMERIC] Volume of aliquots [NUMERIC] [Drop down menu] Volume of last aliquot if less than volume specified above[NUMERIC]

(None)

mL

uL


As of June 1, 2016



As of June 1, 2016


Sample Collection-RNA Sample Collection [LIBRARY 1.2] [EDC VERSION 7]



Date RNA Collected [DATE CONTROL]

[DATE CONTROL]


Number of RNA Tubes Collected [NUMERIC]


As of June 1, 2016


Sample Collection-Sample Collection Questionnaire [LIBRARY 1.2] [EDC VERSION 7]



Date Collected [DATE CONTROL]

[DATE CONTROL]

Did the volunteer consume any caffeinated beverages (coffee, tea, soda) on the day of sample

collection? Yes No

On average, how many caffeinated beverages (coffee, tea, soda) does volunteer consume in a week?

[NUMERIC] /week

Did the volunteer consume any food prior to sample collection? Yes No

Time of last meal: [NUMERIC] : [NUMERIC] (24-hour clock)


As of June 1, 2016


Sample Collection-Serum Sample [LIBRARY 1.3] [EDC VERSION 7]




[TEXT]


Time Collected: [NUMERIC] :[NUMERIC] (24hr clock)

Time started

centrifugation:


Speed of centrifugation: [NUMERIC] x g (times gravity)

Duration of

centrifugation:

[NUMERIC] minutes

Time aliquoted: [NUMERIC] :[NUMERIC] (24hr clock)

Time aliquots put on dry

ice:

[NUMERIC] :[NUMERIC] (24hr clock) N / A

Time aliquots put in -70C

or -80C freezer:


Did serum remain pink

after centrifugation

(indicates hemolysis)?

Yes No

As of June 1, 2016


Number of aliquots Aliquot volume Untis Volume of last aliquot






As of June 1, 2016



As of June 1, 2016


Sample Collection-Urine Sample [LIBRARY 1.1] [EDC VERSION 7]



Date Urine Collected [DATE CONTROL]

[DATE CONTROL]



As of June 1, 2016


Sample Collection - Urine Sample Collection [LIBRARY B v1.0] [EDC VERSION 7]



Date Urine Collected [DATE CONTROL]

[DATE CONTROL]





Volume of aliquots [NUMERIC] [DROPDOWN M

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