Week 3

Question 1

Regulatory Documents

Answer 1

Essential Documents are commonly referred to as regulatory documents. ICH-GCP guidance defines essential documents as those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced

Question 2

Where are regulatory documents stored?

Answer 2

In a double locked environment on site

Question 3

What are regulatory documents filed in?

Answer 3

A regulatory binder

Question 4

Who manages the regulatory binder?

Answer 4

Regulatory coordinator
-The regulatory coordinator’s job is to make sure all required documents are stored in the Regulatory binder at all times

Question 5

Trial Master File (eTMF)

Answer 5

the electronic version of the regulatory binder

Question 6

ICF

Answer 6

The document disclosing all known risks and benefits involved with humans participating in a study

Question 7

Delegation of Authority Log

Answer 7

The roll call sheet listing all employees at the site and their authorized tasks allowed to perform at the site
(PI’s responsibility)

Question 8

Case Report Form(CRF)

Answer 8

A document that original source data is recorded to
- By creating a standardized form for original data and observations to be recorded to it allows for uniformity in record keeping
(usually created by CRO)

Question 9

CRC’s role

Answer 9

• Entering information from source documents accurately to the EDC
• Identifying and document any missing or unknown information on source documents
• visit scheduling and assessment scheduling
• Report protocol deviations, protocol violations, AEs, and SAEs to the IRB when necessary

Question 10

Original Source Reports include

Answer 10

PI verification form
Subject enrollment forms
Eligibility form
Physical examinations
Subject randomization form
Medical History
Lab reports
IP log
Concomitant medication
Off Study form
Death Report form

Question 11

PI Verification Form

Answer 11

The purpose of this form is to obtain PI signature to verify the completion of the CRFs following subject study completion/termination. This form should be signed by the PI only after all the CRFs for the subject are complete and verified by the PI

Question 12

Subject Enrollment Forms

Answer 12

The purpose of this form is to gather demographic information “at baseline”

Question 13

Eligibility Form(inclusion/exclusion criteria)

Answer 13

This form is used “At baseline” to document that the subject satisfies the inclusion and exclusion criteria for the study

Question 14

Physical Examinations

Answer 14

According to the specific directions in the CTP, this form may be required at Baseline and/or at intervals specified by the CTP

Question 15

Subject Randomization Form

Answer 15

Discloses the start and end dates of placebo trial(referred to as “run-in” Dates) and also discloses the date subject began participating in randomization

Question 16

Lab Reports

Answer 16

The purpose of this is to record clinical laboratory data on blood samples

Question 17

IP Log

Answer 17

The purpose of this form is to document pill count or other methods to assess subject compliance and subject evaluability status. Complete this form at the intervals specified by the protocol

Question 18

Concomitant Medication

Answer 18

The purpose of this is to document all combinations of medications taken during the subject’s treatment period

Question 19

Off Study Form

Answer 19

The purpose of this form is to document subject completion, removal form, or drop-out from the study

Question 20

Death Report Form

Answer 20

The purpose of this form is to gather information regarding the subject’s death if it occurred during run-i, treatment, or in follow-up.