As per recent guidelines as put forth by DCGI (see attached office order) accreditation of Ethics Committees is a mandatory step. Shortly, this will become a deciding factor for DCGI to recognize and accept site/EC/investigator for conducting clinical trials in India. Thus, there is an immediate need to get ready and start the application process.

NEED: Majority of ECs have been subjected to NABH inspection and from the overall outcome so far, it is evident that thorough preparedness of EC members to face inspectors and address queries is lacking. Therefore, in order to be well prepared and pass the inspections in first go, an adequate focused attention as well as professional support is recommended.

STEP I: ORIENTATION
Objective: To orient Ethics Committee on NABH Accreditation requirement, role and responsibilities of ECs and guide them through the application process

Module covered will be of half day duration workshop encompassing:

• Latest updates on Indian regulatory requirements as well as GCP.
• Roles of EC members in detail.
• Learning from NABH Audit.
• NABH accreditation requirements - Site/Investigator/Ethics Committee- Important do's and don'ts and application requirements.

STEP II: PROCESS GAP ANLYSIS AND APPLICATION SUBMISSION SUPPORT
Objective: To internally review documentation and processes of Ethics Committee. Identify Gap analysis and work to close Corrective and Preventive action (CAPA)

Duration: Ethics Committee Audit: Half day workshopScope of work:
Scope of work:

• Review of existing EC SOPs and conducting gap analysis.
• Detailed audit report to management with recommended Corrective Action and Preventive Action (CAPA).
• Complete support to sites until successful adoption of CAPA.
• Complete support to sites for submission of successful application to NABH.