Requirements for Human Subject Protection (HSP)/Good Clinical Practice (GCP) Training Frequently Asked Questions
Contents on this page:
Who are considered “key” personnel?
For the purposes of this policy, key personnel are those individuals engaged in the conduct of research as defined by the Office for Human Research Protections who:
- interact with living individuals by performing invasive or noninvasive procedures for research purposes (e.g., drawing blood; collecting other biological samples; dispensing drugs; administering other treatments; employing medical technologies; utilizing physical sensors; utilizing other measurement procedures)" or
- “obtain individually identifiable private information” that is considered to be "engaged" in research.
Examples of key personnel:
- Physicians/clinicians/nurses on staff as full-time, part-time, or on fellowship who interact with study participants or their individually identifiable private information for research purposes.
- Pharmacists, pharmacy technicians, data managers, laboratory staff, and counselors. The level of training may also be at the discretion of the investigator depending the individual’s level of involvement in the research.
All other personnel who are in supporting roles such as couriers, drivers, receptionists, and administrative staff should receive training on protection of participant privacy and confidentiality.
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Who is responsible for ensuring that training in HSP/GCP is obtained for key personnel?
The Principal Investigator (PI) is responsible for ensuring that all personnel receive training appropriate for the individual’s level of involvement in the research. The PI is also responsible for ensuring that new staff (added after the initial award) receive this training within 90 days of assignment to the project and are adequately supervised during the period prior to training.
DAIDS staff whose responsibilities involve clinical research site oversight are responsible for ensuring that HSP training has occurred before a grant is awarded. For questions regarding the appropriate level of training for staff, please contact your DAIDS program officer or the NIAID OPCRO Policy group.
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Can experienced site staff conduct training locally?
Experienced site staff can conduct local training provided that the training content is consistent with the DAIDS policy requirements.
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How do I satisfy the DAIDS training requirements?
The training requirements may be satisfied in one comprehensive training session or several training sessions as long as the requirements below are covered:
- HSP requirements (Section 6.1.1 and subsections)
- GCP requirements (Section 6.1.2 and subsections)
- DAIDS policy requirements: unless otherwise indicated by DAIDS, trainees can meet these requirements by reading and signing off on each policy.
- FDA requirements (Section 6.1.3 and subsections)
The training requirements are listed in the policy:
Requirements for HSP and GCP Training for Clinical Research Site Personnel (PDF)
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What training resources are currently available?
It may take several types of training to fulfill all the requirements of the policy. DAIDS offers regional training events that include many of the required elements. The DAIDS and the HIV/AIDS Network Coordination (HANC) team also provides online training (see below). There may also be training available through your institution. As a reminder, the PI is responsible for determining whether or not any proposed training meets the requirements listed above.
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How should training be documented?
Training records must be maintained at the site and include the trainee’s name, date of training, name/affiliation of trainer, title of course, and primary contents covered in the training (see section 6.1.5).
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How often must site staff be trained?
Clinical research site personnel must receive training 3 years prior to the initiation (i.e., before screening or enrollment of the first subject) of a DAIDS-funded and/or -sponsored study/trial and must receive training every 3 years thereafter.
New clinical research site personnel (hired after study/trial initiation) shall receive HSP and/or GCP training within 90 days of assignment to the project and prior to their functioning without direct supervision, unless the training was received within the past 3 years and documentation is available.
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How much time do I have to achieve compliance?
By June 1, 2008, DAIDS may, at its discretion, request the Clinical Site Monitoring Group (CSMG) monitors to spot-check training documentation for compliance during monitoring visits. Also, appropriate HSP/GCP training documentation for key personnel will be submitted with progress reports for review by the Program Officer.
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Where can I find information on DAIDS Regional Training events?
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