Essential documents - during the clinical conduct of trial Flashcards
INVESTIGATOR’S BROCHURE UPDATES
Located in the files of
1. Investigator
2. Sponsor
ANY REVISION TO:
- Protocol/amendment(s) and CRF
- Informed consent form
- Any other written information provided to subjects
- Advertisement for subject recruitment (if used)
Located in the files of
1. Investigator
2. Sponsor
DATED, DOCUMENTED APPROVAL/FAVORABLE
OPINION OF INSTITUTIONAL REVIEW BOARD
IRB)/INDEPENDENT ETHICS COMMITTEE (IEC)
OF THE FOLLOWING:
* Protocol amendment(s)
* Revision(s) of:
− Informed consent form
− Any other written information to be
provided to the subject
− Advertisement for subject recruitment (if
used)
* Any other documents given approval/favorable
opinion
* Continuing review of trial (where required)
Located in the files of
1. Investigator
2. Sponsor
REGULATORY AUTHORITY(IES)
AUTHORIZATIONS/APPROVALS/NOTIFICATIONS
WHERE REQUIRED FOR:
* Protocol amendment(s) and other documents
Located in the files of
1. Investigator
2. Sponsor
CURRICULUM VITAE FOR NEW
INVESTIGATOR(S) AND/OR
SUBINVESTIGATOR(S)
Located in the files of
1. Investigator
2. Sponsor
UPDATES TO NORMAL VALUE(S)/RANGE(S) FOR
MEDICAL/LABORATORY/TECHNICAL
PROCEDURE(S)/TEST(S) INCLUDED IN THE
PROTOCOL
Located in the files of
1. Investigator
2. Sponsor
UPDATES OF
MEDICAL/LABORATORY/TECHNICAL
PROCEDURES/TESTS
- Certification or
- Accreditation or
- Established quality control and/or external quality
assessment or
- Other validation (where required)
Located in the files of
1. Investigator
2. Sponsor
DOCUMENTATION OF INVESTIGATIONAL
PRODUCT(S) AND TRIAL-RELATED MATERIALS
SHIPMENT
Located in the files of
1. Investigator
2. Sponsor
CERTIFICATE(S) OF ANALYSIS FOR NEW
BATCHES OF INVESTIGATIONAL PRODUCTS
Located in the files of:
1. Sponsor
MONITORING VISIT REPORTS
Located in the files of
1: sponsor
RELEVANT COMMUNICATIONS OTHER THAN
SITE VISITS
- Letters
- Meeting notes
- Notes of telephone calls
Located in the files of
1. Investigator
2. Sponsor
SIGNED INFORMED CONSENT FORMS
Located in the files of
1. Investigator
SOURCE DOCUMENTS
Located in the files of
1. Investigator
SIGNED, DATED, AND COMPLETED CASE
REPORT FORMS (CRF)
Located in the files of
1. Investigator (copy)
2. Sponsor (original)
DOCUMENTATION OF CRF CORRECTIONS
Located in the files of
1. Investigator (copy)
2. Sponsor (original)
NOTIFICATION BY ORIGINATING
INVESTIGATOR TO SPONSOR OF SERIOUS
ADVERSE EVENTS AND RELATED REPORTS
Located in the files of
1. Investigator
2. Sponsor
NOTIFICATION BY SPONSOR AND/OR
INVESTIGATOR, WHERE APPLICABLE, TO
REGULATORY AUTHORITY(IES) AND
IRB(S)/IEC(S) OF UNEXPECTED SERIOUS
ADVERSE DRUG REACTIONS AND OF OTHER
SAFETY INFORMATION
Located in the files of
1. Investigator (where required)
2. Sponsor
NOTIFICATION BY SPONSOR TO
INVESTIGATORS OF SAFETY INFORMATION
Located in the files of
1. Investigator
2. Sponsor
INTERIM OR ANNUAL REPORTS TO IRB/IEC AND
AUTHORITY(IES)
Located in the files of
1. Investigator
2. Sponsor (where required)
SUBJECT SCREENING LOG
Located in the files of
1. Investigator
2. Sponsor (where required)
SUBJECT IDENTIFICATION CODE LIST
Located in the files of
1. Investigator
SUBJECT ENROLMENT LOG
Located in the files of
1. Investigator
INVESTIGATION PRODUCTS ACCOUNTABILITY
AT THE SITE
Located in the files of
1. Investigator
2. Sponsor
SIGNATURE SHEET
Located in the files of
1. Investigator
2. Sponsor
