Roles and Responsibilities

Question 1

Whose responsibility is it to communicate with the IRB/IC?

Answer 1

The investigator

Question 2

Whose responsibility is it to oversee the conduct of the clinical trial at a trial site?

Answer 2

The investigator

Question 3

Whose responsibility is it to manage all aspects of the research conducted at a site?

Answer 3

The investigator

Question 4

Whose responsibility is it to ascertain that the subject has comprehended the research information?

Answer 4

The investigator

Question 5

Whose responsibility is it to oversee IP accountability at the trial site?

Answer 5

The investigator

Question 6

Whose responsibility is it to provide the up-to-date IB to the responsible IRBs/IECs?

Answer 6

The investigator

Question 7

Whose responsibility is it to treat the subject if an Adverse Event occurs?

Answer 7

The investigator

Question 8

Whose responsibility is it to report Serious and fatal or life-threatening AE?

Answer 8

The investigator

Question 9

Whose responsibility is it to report Serious and non-fatal or life-threatening AE?

Answer 9

The investigator

Question 10

Whose responsibility is it to report SAEs which occur after the patient has completed a clinical study?

Answer 10

The investigator

Question 11

Whose responsibility is it to design the clinical trial protocol?

Answer 11

The sponsor

Question 12

Whose responsibility is it to ensure quality and integrity of the data in a contracted trial?

Answer 12

The sponsor

Question 13

Whose responsibility is it to secure an agreement from all involved parties to ensure monitoring and auditing?

Answer 13

The sponsor

Question 14

Whose responsibility is it to implement and maintain quality assurance and quality control systems?

Answer 14

The sponsor

Question 15

Whose responsibility is it to maintain an audit trail, data trail, and edit trail in the EDC?

Answer 15

The sponsor

Question 16

Whose responsibility is it to supply the IP?

Answer 16

The sponsor

Question 17

Whose responsibility is it to oversee ongoing safety evaluation of IP?

Answer 17

The sponsor

Question 18

Whose responsibility is it to determine acceptable IP storage temperatures/ conditions?

Answer 18

The sponsor

Question 19

Whose responsibility is it to maintain the IB up to date?

Answer 19

The sponsor

Question 20

Whose responsibility is it to decide whether active comparator drug reactions should be reported to the other manufacturer and/or directly to appropriate regulatory agencies?

Answer 20

The sponsor

Question 21

Whose responsibility is it to ensure that statistical principles are implemented properly?

Answer 21

The sponsor

Question 22

Whose responsibility is it to perform Source Data Verification (SDV)?

Answer 22

CRA

Question 23

Whose responsibility is it to verify subject protection?

Answer 23

CRA

Question 24

Whose responsibility is it to confirm data recorded are verifiable from source documents?

Answer 24

CRA

Question 25

Whose responsibility is it to ensure protocol compliance?

Answer 25

CRA

Question 26

Whose responsibility is it to ensure all participating subjects are protected?

Answer 26

IRB

Question 27

Whose responsibility is it to maintain a list of qualified persons to whom trial-related duties are delegated?

Answer 27

The investigator

Question 28

Whose responsibility is it to supervise any individual or party to whom is delegated trial-related duties?

Answer 28

The investigator

Question 29

Whose responsibility is it to demonstrate the potential to recruit the required number of suitable subjects?

Answer 29

The investigator

Question 30

Whose responsibility is it to permit monitoring, auditing, and inspection?

Answer 30

The investigator

Question 31

Whose responsibility is it to inform institution when records no longer need to be retained?

Answer 31

The sponsor

Question 32

Whose responsibility is it to perform risk control?

Answer 32

The sponsor

Question 33

Whose responsibility is it to submit safety updates and periodic reports to regulatory authorities?

Answer 33

The sponsor

Question 34

Whose responsibility is it to terminate an investigator’s participation in case of serious noncompliance?

Answer 34

The sponsor

Question 35

Whose responsibility is it to inform all parties of trial termination or suspension and the reasons for it?

Answer 35

The sponsor

Question 36

Whose responsibility is it to ensure clinical trial reports are prepared and provided to regulatory authorities?

Answer 36

The sponsor

Question 37

Whose responsibility is it to select trial investigators/institutions?

Answer 37

The sponsor

Question 38

Whose responsibility is it to ensure the investigator is qualified?

Answer 38

IRB

Question 39

Whose responsibility is it to pay special attention to trials that may include vulnerable subjects?

Answer 39

IRB

Question 40

Whose responsibility is it to review a proposed clinical trial and provide decision with reasoning ?

Answer 40

IRB

Question 41

Whose responsibility is it to conduct continuing review of each ongoing trial?

Answer 41

IRB