This section provides answers to the frequently asked questions (FAQs) regarding the Requirements for Human Subject Protection (HSP)/Good Clinical Practice (GCP) Training:
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
Examples of key personnel:
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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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.
Experienced site staff can conduct local training provided that the training content is consistent with the DAIDS policy requirements.
The training requirements may be satisfied in one comprehensive training session or several training sessions as long as the requirements below are covered:
The training requirements are listed in the policy:
Requirements for HSP and GCP Training for Clinical Research Site Personnel (PDF)
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.
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).
Clinical research site personnel must receive training three 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 three 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 three years and documentation is available.
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.
Last Updated March 23, 2012