1 us investigator meeting dias-4, chicago, july 2011 good clinical practice (gcp) for investigators...

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


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


Agenda

GCP responsibility for Investigator and Research team

The 12 Golden GCP rules

Question & answer


Rule number 1

Know and Follow the Study Protocol

Read it

Agree it

Sign it

Follow It

Make it available

File it


Rule number 2

Select, train and log your study personnel

Investigators’ CVs

Keep people informed

Log of study personnel


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


Rule number 3

Record Data Carefully

Complete… timely, correctly, all required data

Avoid… missing data

Date and initial (we use eCRF: PASSWORD)…


Rule number 4

Ensure that you study equipments are adequate

Suitable…

Calibrated and Checked…

Available…

Maintained…

= SCAM


Rule number 5

Maximise your patients’ protection

IRB approval

Informed Consent (IC)


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.


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.


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


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


Rule number 8

Ensure timely and efficient safety reporting

Adverse Event (AE)

Serious Adverse Event (SAE)


Rule number 9

Ensure the quality of laboratory evaluations

Laboratory results and requests

CT or MRI scan


Rule number 10

Maintain good trial files and archives

’If it is not documented, it doesn't exist’!

Storage of the documentation


Rule number 11

Maximise data quality

Monitoring by CRA

Medical notes

Source Data Identification form


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


Rule number 12

Keep everyone fully informed

Patient andCaregiver

EC

Sponsor

SAE reporting

Study research team

CRA


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


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

1 us investigator meeting dias-4, chicago, july 2011 good clinical practice (gcp) for investigators...

Documents

us investigator meeting

gcp investigator

principal investigator

rule number

documentation slide

scam slide

logs slide

password slide