Essential documents - before the clinical phase of the trial commences

Question 1

Investigator brochure

Answer 1

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 2

Signed protocol and amendments and CRFs

Answer 2

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 3

INFORMATION GIVEN TO TRIAL SUBJECT
- INFORMED CONSENT FORM

Any other written info

Advertisement for subject recruitment

Answer 3

Located in files of
1. Investigator/ Institution
2. Sponsor

Located in files of
1. Investigator/ Institution
2. Sponsor

Located in files of
1. Investigator/ Institution

Question 4

FINANCIAL ASPECTS OF THE TRIAL

Answer 4

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 5

insurance statement

Answer 5

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 6

SIGNED AGREEMENT BETWEEN INVOLVED
PARTIES, e.g.:
- Investigator/institution and sponsor
- Investigator/institution and CRO
- Sponsor and CRO
- Investigator/institution and authority(ies)
(where required)

Answer 6

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 7

DATED, DOCUMENTED
APPROVAL/FAVORABLE OPINION OF
INSTITUTIONAL REVIEW BOARD
(IRB)/INDEPENDENT ETHICS COMMITTEE
(IEC) OF THE FOLLOWING:
* Protocol and any amendments
* CRF (if applicable)
* Informed consent form(s)
* Any other written information to be provided
to the subject(s)
* Advertisement for subject recruitment (if used)
* Subject compensation (if any)
* Any other documents given approval/favorable
opinion

Answer 7

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 8

INSTITUTIONAL REVIEW
BOARD/INDEPENDENT ETHICS COMMITTEE
COMPOSITION

Answer 8

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 9

REGULATORY AUTHORITY(IES)
AUTHORIZATION/APPROVAL/NOTIFICATION
OF PROTOCOL (where required)

Answer 9

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 10

CURRICULUM VITAE AND/OR OTHER
RELEVANT DOCUMENTS EVIDENCING
QUALIFICATIONS OF INVESTIGATOR(S) AND
SUBINVESTIGATOR(S)

Answer 10

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 11

NORMAL VALUE(S)/RANGE(S) FOR
MEDICAL/LABORATORY/TECHNICAL
PROCEDURES(S) AND/OR TEST(S) INCLUDED
IN THE PROTOCOL

Answer 11

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 12

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

Answer 12

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 13

SAMPLE OF LABEL(S) ATTACHED TO
INVESTIGATIONAL PRODUCT CONTAINER(S)

Answer 13

Located in files of
1. Sponsor

Question 14

INSTRUCTIONS FOR HANDLING OF
INVESTIGATIONAL PRODUCT(S) AND TRIALRELATED MATERIALS (if not included in
protocol or Investigator’s Brochure)

Answer 14

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 15

SHIPPING RECORDS FOR INVESTIGATIONAL
PRODUCT(S) AND TRIAL-RELATED
MATERIALS

Answer 15

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 16

CERTIFICATE(S) OF ANALYSIS OF
INVESTIGATIONAL PRODUCT(S) SHIPPED

Answer 16

Located in files of
1. Sponsor

Question 17

DECODING PROCEDURES FOR BLINDED
TRIALS

Answer 17

Located in files of
1. Investigator/ Institution
2. Sponsor

Question 18

MASTER RANDOMIZATION LIST

Answer 18

Located in files of
1. Sponsor

Question 19

PRE-TRIAL MONITORING REPORT

Answer 19

Located in files of
1. Sponsor

Question 20

TRIAL INITIATION MONITORING REPORT

Answer 20

Located in files of
1. Investigator/ Institution
2. Sponsor