Sponsor Responsibilities - ICH

Question 1

Responsibilities of Sponsor

Answer 1

1. Quality Management
2. Trial Design
3. Trial Managment
4. Designating CRO’s
5. Selecting investigator and sponsors
6. Recieving IRB/IEC approval
7. Compensation to subjects/investigators
8. Manufacturing, Packaging, Labeling, and Coding information
9. Supply and handling information
10. Safety evaluation/information
11. Adverse drug reporting

Question 2

Quality Management

Answer 2

-Big 6 Risks
1. Risk Review - sponsor should periodically review risk control measures
2. Risk Control - sponsor should decide which risks to reduce and which risks to accept
3. Risk Evaluation - evaluating 1) likelihood of errors occuring, 2) extenet to which errors were detectable, 3)impact of errors on human subjects
4. Risk Communication - sponsor should document quality management activities
5. Risk reporting - sponsor should describe QM approach implemented in trial and summarize important deviations
6. risk identification - identifying risks to critical trial processes and data at both system level and clinical trial level

Question 3

Trial Design

Question 4

Designating CRO’s

Answer 4

-CRO’s are appointed by the sponsor
-Sponsor assumes ultimate responsibiltity over CRO’s

Question 5

Selecting investigators and monitors

Answer 5

-Sponrs appoint investigators
-Sponsors appoint monitors

Question 6

Compensation to subject/investigators

Question 7

IRB/IEC Approval Confirmation

Answer 7

Sponsors need:
1. Name and address of IRB
2. statement that IRB will conduct protocol according to GCP an applicable regulations
3. IRB/IEC Approval

Question 8

Manufacturing, Labeling, Packaging, and Coding of the Investigational Product

Question 9

Supplying and Handling of the Investigational Product

Question 10

Safety evaluation/Information

Question 11

Adverse Drug Reporting

Answer 11

-Sponsor reports to the investigator/institution

Question 12

Trial Management

Answer 12

Sponsor ensures that trials are adequately monitored