Essential Documents

Question 1

Investigator’s Brochure

Answer 1

BOTH, Before Trial. To document that relevant and current scientific information about the investigational product has been provided to the investigator.

Question 2

Signed protocol and amendments, if any, and sample case report form.

Answer 2

BOTH, before trial. To document investigator and sponsor agreement to the protocol/amendments and CRF

Question 3

Information given to trial subject
- Informed consent form (including all applicable translations)

Answer 3

BOTH, before trial. To document informed consent

Question 4

Information given to trial subject
-any other written information

Answer 4

BOTH, before trial. To document that subjects will be given appropriate written information (content and wording) to support their ability to give fully informed consent.

Question 5

Advertisement for subject recruitment (if used)

Answer 5

INVESTIGATOR ONLY, before trial. To document that recruitment measures are appropriate and not coercive.

Question 6

Financial aspects of the trial

Answer 6

BOTH, before the study. To document the financial agreement between the investigator/institution and the sponsor for the trial.

Question 7

Insurance Statement (where required)

Answer 7

BOTH, before the study. To document that compensation to subject(s) for trial related injury will be available.

Question 8

Signed agreement between involved parties:
- investigator and sponsor
-investigator and CRO
-sponsor and CRO
-Investigator and authorities

Answer 8

Before trial,To document agreements
-BOTH
-BOTH
-SPONSOR ONLY
-BOTH

Question 9

DATED, DOCUMENTED APPROVAL/FAVOURABLE 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/ favourable opinion

Answer 9

BOTH, before trial
To document that the trial has been subject to
IRB/IEC review and given approval/favourable opinion. To identify the version number and date of the document(s)

Question 10

INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE COMPOSITION

Answer 10

BOTH, Before Trial. To document that the IRB/IEC is constituted in agreement with GCP

Question 11

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

Answer 11

BOTH (where required), before trial. To document appropriate authorisation/approval/notification by the regulatory authority(ies) has been obtained prior to initiation of the trial in compliance with the applicable regulatory requirement(s)

Question 12

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

Answer 12

BOTH, before trial. To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects

Question 13

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

Answer 13

BOTH, before trial. To document normal values and/or ranges of the tests

Question 14

MEDICAL/LABORATORY/TECHNICAL PROCEDURES /TESTS
- certification or
- accreditation or
- established quality control and/or external quality assessment or
- other validation (where required)

Answer 14

BOTH (Investigator where required), before trial. To document competence of facility to perform required test(s), and support reliability of results

Question 15

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

Answer 15

Sponsor only, before trial. To document compliance with applicable labelling regulations and appropriateness of instructions provided to the subjects

Question 16

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

Answer 16

BOTH, before trial. To document instructions needed to ensure proper storage, packaging, dispensing and disposition of investigational products and trial-related materials

Question 17

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

Answer 17

BOTH, before trial. To document shipment dates, batch numbers and method of shipment of investigational product(s) and trial-related materials. Allows tracking of product batch, review of shipping conditions, and accountability

Question 18

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

Answer 18

SPONSOR ONLY, before trial. To document identity, purity, and strength of investigational product(s) to be used in the trial

Question 19

DECODING PROCEDURES FOR BLINDED TRIALS

Answer 19

BOTH, before trial. To document how, in case of an emergency, identity of blinded investigational product can be revealed without breaking the blind for the remaining subjects’ treatment

Question 20

MASTER RANDOMISATION LIST

Answer 20

SPONSOR ONLY, before trial. To document method for randomisation of trial population

Question 21

PRE-TRIAL MONITORING REPORT

Answer 21

SPONSOR ONLY, before trial. To document that the site is suitable for the trial (may be combined with 8.2.20)

Question 22

TRIAL INITIATION MONITORING REPORT

Answer 22

BOTH, before trial To document that trial procedures were reviewed with the investigator and the investigator’s trial staff

Question 23

INVESTIGATOR’S BROCHURE UPDATES

Answer 23

BOTH, during the trial. To document that investigator is informed in a timely manner of relevant information as it becomes available

Question 24

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 24

BOTH, during the trial. To document revisions of these trial related documents that take effect during trial.

Question 25

DATED, DOCUMENTED APPROVAL/FAVOURABLE 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/favourable opinion - continuing review of trial (where required)

Answer 25

BOTH, during the trial. To document that the amendment(s) and/or revision(s) have been subject to IRB/IEC review and were given approval/favourable opinion. To identify the version number and date of the document(s).

Question 26

REGULATORY AUTHORITY(IES) AUTHORISATIONS/APPROVALS/NOTIFICATIONS WHERE REQUIRED FOR: - protocol amendment(s) and other documents

Answer 26

BOTH (Investigator where applicable), during the trial. To document compliance with applicable regulatory requirements

Question 27

CURRICULUM VITAE FOR NEW INVESTIGATOR(S) AND/OR SUB-INVESTIGATOR(S)

Answer 27

BOTH, during the trial.

Question 28

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

Answer 28

BOTH, during the trial. To document normal values and ranges that are revised during the trial (see 8.2.11)

Question 29

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 29

BOTH (investigator where required), during the trial. To document that tests remain adequate throughout the trial period (see 8.2.12)

Question 30

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

Answer 30

BOTH, during the trial

Question 31

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

Answer 31

SPONSOR ONLY, during the trial

Question 32

MONITORING VISIT REPORTS

Answer 32

SPONSOR ONLY, during the trial. To document site visits by, and findings of, the monitor

Question 33

RELEVANT COMMUNICATIONS OTHER THAN SITE VISITS - letters - meeting notes - notes of telephone calls

Answer 33

BOTH, during the trial. To document any agreements or significant discussions regarding trial administration, protocol violations, trial conduct, adverse event (AE) reporting

Question 34

SIGNED INFORMED CONSENT FORMS

Answer 34

INVESTIGATOR ONLY, during the trial. To document that consent is obtained in accordance with GCP and protocol and dated prior to participation of each subject in trial. Also to document direct access permission (see 8.2.3)

Question 35

SOURCE DOCUMENTS

Answer 35

INVESTIGATOR ONLY, during the trial. To document the existence of the subject and substantiate integrity of trial data collected. To include original documents related to the trial, to medical treatment, and history of subject

Question 36

SIGNED, DATED AND COMPLETED CASE REPORT FORMS (CRF)

Answer 36

BOTH (investigator gets copy, sponsor original), during trial. To document that the investigator or authorised member of the investigator’s staff confirms the observations recorded

Question 37

DOCUMENTATION OF CRF CORRECTIONS

Answer 37

BOTH (investigator gets copy, sponsor original), during trial. To document all changes/additions or corrections made to CRF after initial data were recorded

Question 38

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

Answer 38

BOTH, during the trial. Notification by originating investigator to sponsor of serious adverse events and related reports in accordance with 4.11

Question 39

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 39

BOTH (investigator where applicable), during the trial. Notification by sponsor and/or investigator, where applicable, to regulatory authorities and IRB(s)/IEC(s) of unexpected serious adverse drug reactions in accordance with 5.17 and 4.11.1 and of other safety information in accordance with 5.16.2 and 4.11.2

Question 40

NOTIFICATION BY SPONSOR TO INVESTIGATORS OF SAFETY INFORMATION

Answer 40

BOTH, during the trial. Notification by sponsor to investigators of safety information in accordance with 5.16.2

Question 41

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

Answer 41

BOTH (Sponsor where required), during the trial. Interim or annual reports provided to IRB/IEC in accordance with 4.10 and to authority(ies) in accordance with 5.17.3

Question 42

SUBJECT SCREENING LOG

Answer 42

BOTH (sponsor where required), during the trial. To document identification of subjects who entered pre-trial screening.

Question 43

SUBJECT IDENTIFICATION CODE LIST

Answer 43

INVESTIGATOR ONLY, during trial. To document that investigator/institution keeps a confidential list of names of all subjects allocated to trial numbers on enrolling in the trial. Allows investigator/institution to reveal identity of any subject

Question 44

SUBJECT ENROLMENT LOG

Answer 44

INVESTIGATOR ONLY, during trial. To document chronological enrolment of subjects by trial number

Question 45

INVESTIGATIONAL PRODUCTS ACCOUNTABILITY AT THE SITE

Answer 45

BOTH, during the trial. To document that investigational product(s) have been used according to the protocol

Question 46

SIGNATURE SHEET

Answer 46

BOTH, during the trial. To document signatures and initials of all persons authorised to make entries and/or corrections on CRFs

Question 47

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

Answer 47

BOTH, during the study. To document location and identification of retained samples if assays need to be repeated

Question 48

INVESTIGATIONAL PRODUCT(S) ACCOUNTABILITY AT SITE

Answer 48

BOTH, after the trial. To document that the investigational product(s) have been used according to the protocol. To documents the final accounting of investigational product(s) received at the site, dispensed to subjects, returned by the subjects, and returned to sponsor

Question 49

DOCUMENTATION OF INVESTIGATIONAL PRODUCT DESTRUCTION

Answer 49

BOTH (required for investigator's if IP destroyed at investigator site). To document destruction of unused investigational products by sponsor or at site

Question 50

COMPLETED SUBJECT IDENTIFICATION CODE LIST

Answer 50

INVESTIGATOR ONLY, after the trial. To permit identification of all subjects enrolled in the trial in case follow-up is required. List should be kept in a confidential manner and for agreed upon time

Question 51

AUDIT CERTIFICATE (if available)

Answer 51

SPONSOR only, after the trial. To document that audit was performed

Question 52

FINAL TRIAL CLOSE-OUT MONITORING REPORT

Answer 52

SPONSOR ONLY, to document that all activities required for trial close-out are completed, and copies of essential documents are held in the appropriate files.

Question 53

TREATMENT ALLOCATION AND DECODING DOCUMENTATION

Answer 53

SPONSOR ONLY, after the trial. Returned to sponsor to document any decoding that may have occurred

Question 54

FINAL REPORT BY INVESTIGATOR TO IRB/IEC WHERE REQUIRED, AND WHERE APPLICABLE, TO THE REGULATORY AUTHORITY(IES)

Answer 54

INVESTIGATOR ONLY, after the trial. To document completion of the trial

Question 55

CLINICAL STUDY REPORT

Answer 55

BOTH (investigator if applicable), after the trial. to document results and interpretation of the trial.