1 us investigator meeting dias-4, chicago, july 2011 good clinical practice (gcp) for investigators...
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1 US Investigator Meeting DIAS-4, Chicago, July 2011
Good Clinical Practice(GCP)
for Investigators and the Research Team
2US Investigator Meeting DIAS-4, Chicago, July 2011
What kind of audit findings
1. Lack of information in medical record
2. Enrolment of patients who violate the exclusion or do not fulfil the inclusion criteria
3. Unreported AEs in the CRF
4. Lack of time for the Principal Investigator to perform the trial
5. Investigator signed Informed Consent before the patient
6. Failure of the site to complete and maintain the IMP records
3US Investigator Meeting DIAS-4, Chicago, July 2011
GCP ensures that:
Patients rights, safety, and well-being are protected
Clinical trials are based on good science, are well designed and properly analysed
The study procedures are properly undertaken and documented
Why follow GCP?
If GCP is not followed:
The patients could be exposed to unnecessary risks
The data collected may be unreliable
The clinical trial can be rejected
4US Investigator Meeting DIAS-4, Chicago, July 2011
Agenda
GCP responsibility for Investigator and Research team
The 12 Golden GCP rules
Question & answer
5US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 1
Know and Follow the Study Protocol
Read it
Agree it
Sign it
Follow It
Make it available
File it
6US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 2
Select, train and log your study personnel
Investigators’ CVs
Keep people informed
Log of study personnel
7US Investigator Meeting DIAS-4, Chicago, July 2011
Example of the Log of Study Personnel
Example
Name (capital letters)
Trial Function* (capital letters)
Trial related duties* (Insert
numbers)
Signature
Initial & Date (short
signature)
PI Initial &
Date (for approval)
Stop date Only if before
closeout
DR. J OHN BROWN
PRINCIPAL INVESTIGATOR
N/A N/A
FLORENCE NI GHTI NGALE
STUDY NURSE
2 7, 8, 9
* Items listed in bold can only be performed by a physician
(1) EC/IRB communication (4) History (med, psych, neurol) (7) Vital signs, height (2) Oral Informed Consent (5) Demographics, height (8) Biochemistry/haematology (3) Obtain Written Informed Consent (6) Physic/Neurol Examination (9) Record ECG
8US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 3
Record Data Carefully
Complete… timely, correctly, all required data
Avoid… missing data
Date and initial (we use eCRF: PASSWORD)…
9US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 4
Ensure that you study equipments are adequate
Suitable…
Calibrated and Checked…
Available…
Maintained…
= SCAM
10US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 5
Maximise your patients’ protection
IRB approval
Informed Consent (IC)
11US Investigator Meeting DIAS-4, Chicago, July 2011
Patient and investigator signed on the respective
part of the IC but did not date and time.
The study coordinator noticed this and dated it on behalf of the investigator and the patient.
Is this correct according to GCP?
Case 1 - Consent
No, this is non-compliant with GCP – Investigator and
patient (or witness or legal representative) must personally sign and date and time the informed consent.
12US Investigator Meeting DIAS-4, Chicago, July 2011
Can a study coordinator take informed consent?
Case 2 - Consent
In Lundbeck studies, the study coordinator can take part in the discussion with the patient about the study and
the patient information sheet
- but the investigator must always be involved and only
the investigator can obtain the Informed Consent.
13US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 6
Predict accurately and log your patient
recruitment
Select the right patients (in and exclusion criteria)
If a patient decides to withdraw try to obtain and record the reason if possible
Keep the patients listed in logs
14US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 7
Thorough documentation of study drug flow
Storage at site according to requirements
Document receipt, administration, storage, and return of study drug
If IMP was stored outside temperature limits – even for a minimum period of time – contact your monitor immediately
15US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 8
Ensure timely and efficient safety reporting
Adverse Event (AE)
Serious Adverse Event (SAE)
16US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 9
Ensure the quality of laboratory evaluations
Laboratory results and requests
CT or MRI scan
17US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 10
Maintain good trial files and archives
’If it is not documented, it doesn't exist’!
Storage of the documentation
18US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 11
Maximise data quality
Monitoring by CRA
Medical notes
Source Data Identification form
19US Investigator Meeting DIAS-4, Chicago, July 2011
Source Document Identification
Date and result of: CRF
Patients medical record/notes
Other source - please specify
(e.g. nurse’s notes)
Patient identification
Date of visit
Informed Consent
Please complete the form by marking (one tick) where of the clinical trial data will be entered first
X
X
X
20US Investigator Meeting DIAS-4, Chicago, July 2011
Rule number 12
Keep everyone fully informed
Patient andCaregiver
EC
Sponsor
SAE reporting
Study research team
CRA
21US Investigator Meeting DIAS-4, Chicago, July 2011
GCP ensures that:
Patients rights, safety, and well-being are protected
Clinical trials are based on good science, are well designed and properly analysed
The study procedures are properly undertaken and documented
Keep the number of audits findings down
Q and A
22US Investigator Meeting DIAS-4, Chicago, July 2011
GCP Definitions
Gun Control Panel Gateway Control Protocol
God’s Child Project
Grand Central Partnership
Great Circus Parade
Ground Control Position
Ground Control Planning
Green City Project
Great-Circle Path
Grand Central Parkway
Thank you!
Good Clinical Practice
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