Staff involved in the conduct of a clinical trial, across all sites must be trained with the help of Good Clinical Practice (GCP) guidelines, applicable SOPs and trial specific documents. Training of site staff is essential to ensure uniformity and compliance. Following is a suggestive list of documents that the site staff should be trained in:

Standard guidelines and regulations that are available:

1. Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online.
2. New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available online.
3. National Ethical Guidelines for Biomedical and Health Research involving Human Participants, Indian Council of Medical Research, 2017, available online.
4. ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9^th November 2016, available online(if applicable).

Trial-specific processes and documents:

1. Approved Protocol and amendments, if any: This should be a detailed training, including eligibility criteria, participant and data flow, study procedures, etc.
2. Informed Consent Documents and process of obtaining consent.
3. Investigator Brochure (IB).
4. Recruitment process: Process of screening potential participants and appropriate method of obtaining informed consent.
5. Case Record Form (CRF): Staff should be trained with the help of CRF Completion Manual, relevant SOPs (if available) and query management. If specific equipment is to be used for electronic data capture (eCRF), then, these must be utilised for training.
6. Investigational Product (IP): Depending on the trial, the staff must be trained in IP handling, storage, retrieval, destruction, etc.
7. Documentation: The staff must be trained in filing and maintenance of Investigator Site File (ISF) (as applicable).
8. Safety Reporting: The staff should be aware of the applicable timelines for reporting Adverse and Serious Adverse Events, and the forms that are to be completed.
9. Protocol Deviation: The staff should be aware of the procedure to be followed in the event of a deviation from protocol (notification to the Ethics Committee, CDSCO and sponsor).
10. Duty Delegation Log: With the help of a duty delegation log, the staff should be made aware of their specific responsibilities. This log also enlists the logs and forms that have to be completed, as per the regulatory requirements.
11. Any other specific activities (if planned). Some examples are:

• If the trial includes sample collection and transport to an external laboratory, then, designated site staff should be made aware of the process to be followed for the transport, and appropriate logs and forms that are to be completed.
• Specific follow-up procedures to be followed
• If any sub-studies are planned, then, the staff must be aware of the procedures to be followed for these.
• Preparation for monitoring visits (if planned)
• Completion of any other participant material like questionnaires, diaries, etc.
• IATA (International Air Transport Association) guidelines, if applicable.

It is advisable that the site investigator and the monitoring team ensure ongoing training and development of the site staff. On the basis of their evaluation, re-training of the site staff may be conducted.

References

• Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
• ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9^th November 2016, available online (last accessed on 26.02.2019).
• National Ethical Guidelines for Biomedical and Health Research involving Human Participants, Indian Council of Medical Research, 2017, available online (last accessed on 26.02.2019).