Study Reviews (Audits)

Regular study reviews (audits) are essential to ensure compliance of research being conducted in NHG and its partner institutions. The focus of study reviews is to help investigators with proper conduct of research.

Random study reviews are conducted by the NHG Research Quality Management (RQM) Unit. Study reviews may also be initiated for cause i.e. when a review is initiated to investigate issues or complaints. For cause study reviews may be conducted by the NHG RQM Unit or by external auditors appointed by NHG Group Research & Innovation.

Some of the reasons for initiating for cause reviews include:

Request by Investigator/other members of the research team
Request by Institutional Representatives/other staff of the institution
Request by DSRB/REC
Subject/family member of subject complaints

Study reviews may be conducted onsite, remotely, or a combination of both (hybrid).

Site visits would generally involve an opening meeting with the PI and study team, followed by a review of the study documentation and facilities. At the end of the visit, a close out meeting would be conducted to discuss any observations and findings noted with the PI and study team.

The scope of review may include the following but not limited to:

IRB/Regulatory Applications and Approvals
Study Team Delegation, Training and Qualifications
Informed Consent Process and Documentation (e.g. signed ICF)
Subject Recruitment Process
Data Collection and Source Documentation (e.g. medical records, completed study forms)
Biological Specimen Management
Investigational Product Management
Investigator File
Research Database

Appropriate measures and remedies to rectify any non-compliance or inadequacies detected during study reviews will be recommended in the detailed audit report. The PI would be required to take actions in accordance to auditor’s recommendations and submit a Corrective and Preventive Action (CAPA) plan within a stipulated timeline.