Which member of the clinical trial team is responsible for the overall conduct of the trial at a study site?

Question

BlackTom AI · Accepted Answer

The Principal Investigator (PI) holds ultimate responsibility for the overall conduct of the trial at a study site.

1) Relevant knowledge points and concepts
- ICH-GCP and standard clinical research practice assign the site-level responsibility to the Principal Investigator (PI). The PI ensures the trial is conducted according to the protocol, applicable regulations, and Good Clinical Practice.
- Sponsor responsibilities are broader (designing the trial, funding, overall oversight) but not day-to-day conduct at a specific site.
- A Clinical Research Associate (CRA) monitors sites and verifies compliance but does not assume legal/site responsibility.
- Nurses and other site staff perform delegated tasks under the PI’s supervision.

2) Step-by-step reasoning
- Identify who is accountable for site conduct: regulations and guidance name the PI as the person responsible for protection of subjects, integrity of data, and protocol compliance at the site.
- Evaluate each option:
  a. Principal Investigator — defined role includes initiating, conducting, and managing the trial at that site; obtaining IRB/ethics approval; ensuring informed consent; supervising staff; maintaining records.
  b. Nurse — may perform clinical tasks (administering treatment, assessments) but acts under PI delegation and lacks overall site responsibility.
  c. Sponsor — responsible for overall trial design, funding, and oversight, but not direct site conduct responsibility.
  d. CRA — conducts monitoring visits to verify data and compliance; supports sponsor oversight but does not have ultimate authority/responsibility for site conduct.

3) Calculations/intermediate steps
- Not applicable.

4) Why the correct answer is correct
- The PI is legally and ethically accountable at the site level for subject safety, adherence to protocol, delegation, and record-keeping, per GCP.

5) Why other options are incorrect (brief)
- Nurse: delegated role, not overall responsibility.
- Sponsor: overall trial owner, not site-level conductor.
- CRA: monitor/validator, not the site’s responsible party.

Conclusion: The correct answer is a. Principal Investigator, which matches the provided answer.

Which member of the clinical trial team is responsible for the overall conduct of the trial at a study site?单项选择题

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