Essential documents - during the clinical conduct of trial

Question 1

INVESTIGATOR’S BROCHURE UPDATES

Answer 1

Located in the files of
1. Investigator
2. Sponsor

Question 2

ANY REVISION TO:
- Protocol/amendment(s) and CRF
- Informed consent form
- Any other written information provided to subjects
- Advertisement for subject recruitment (if used)

Answer 2

Located in the files of
1. Investigator
2. Sponsor

Question 3

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)

Answer 3

Located in the files of
1. Investigator
2. Sponsor

Question 4

REGULATORY AUTHORITY(IES)
AUTHORIZATIONS/APPROVALS/NOTIFICATIONS
WHERE REQUIRED FOR:
* Protocol amendment(s) and other documents

Answer 4

Located in the files of
1. Investigator
2. Sponsor

Question 5

CURRICULUM VITAE FOR NEW
INVESTIGATOR(S) AND/OR
SUBINVESTIGATOR(S)

Answer 5

Located in the files of
1. Investigator
2. Sponsor

Question 6

UPDATES TO NORMAL VALUE(S)/RANGE(S) FOR
MEDICAL/LABORATORY/TECHNICAL
PROCEDURE(S)/TEST(S) INCLUDED IN THE
PROTOCOL

Answer 6

Located in the files of
1. Investigator
2. Sponsor

Question 7

UPDATES OF
MEDICAL/LABORATORY/TECHNICAL
PROCEDURES/TESTS
- Certification or
- Accreditation or
- Established quality control and/or external quality
assessment or
- Other validation (where required)

Answer 7

Located in the files of
1. Investigator
2. Sponsor

Question 8

DOCUMENTATION OF INVESTIGATIONAL
PRODUCT(S) AND TRIAL-RELATED MATERIALS
SHIPMENT

Answer 8

Located in the files of
1. Investigator
2. Sponsor

Question 9

CERTIFICATE(S) OF ANALYSIS FOR NEW
BATCHES OF INVESTIGATIONAL PRODUCTS

Answer 9

Located in the files of:
1. Sponsor

Question 10

MONITORING VISIT REPORTS

Answer 10

Located in the files of
1: sponsor

Question 11

RELEVANT COMMUNICATIONS OTHER THAN
SITE VISITS
- Letters
- Meeting notes
- Notes of telephone calls

Answer 11

Located in the files of
1. Investigator
2. Sponsor

Question 12

SIGNED INFORMED CONSENT FORMS

Answer 12

Located in the files of
1. Investigator

Question 13

SOURCE DOCUMENTS

Answer 13

Located in the files of
1. Investigator

Question 14

SIGNED, DATED, AND COMPLETED CASE
REPORT FORMS (CRF)

Answer 14

Located in the files of
1. Investigator (copy)
2. Sponsor (original)

Question 15

DOCUMENTATION OF CRF CORRECTIONS

Answer 15

Located in the files of
1. Investigator (copy)
2. Sponsor (original)

Question 16

NOTIFICATION BY ORIGINATING
INVESTIGATOR TO SPONSOR OF SERIOUS
ADVERSE EVENTS AND RELATED REPORTS

Answer 16

Located in the files of
1. Investigator
2. Sponsor

Question 17

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

Answer 17

Located in the files of
1. Investigator (where required)
2. Sponsor

Question 18

NOTIFICATION BY SPONSOR TO
INVESTIGATORS OF SAFETY INFORMATION

Answer 18

Located in the files of
1. Investigator
2. Sponsor

Question 19

INTERIM OR ANNUAL REPORTS TO IRB/IEC AND
AUTHORITY(IES)

Answer 19

Located in the files of
1. Investigator
2. Sponsor (where required)

Question 20

SUBJECT SCREENING LOG

Answer 20

Located in the files of
1. Investigator
2. Sponsor (where required)

Question 21

SUBJECT IDENTIFICATION CODE LIST

Answer 21

Located in the files of
1. Investigator

Question 22

SUBJECT ENROLMENT LOG

Answer 22

Located in the files of
1. Investigator

Question 23

INVESTIGATION PRODUCTS ACCOUNTABILITY
AT THE SITE

Answer 23

Located in the files of
1. Investigator
2. Sponsor

Question 24

SIGNATURE SHEET

Answer 24

Located in the files of
1. Investigator
2. Sponsor

Question 25

RECORD OF RETAINED BODY FLUIDS/TISSUE
SAMPLES (IF ANY)

Answer 25

Located in the files of
1. Investigator
2. Sponsor