GOOD CLINICAL PRACTICE PROFESSIONAL CERTIFICATION SCHEME (GCPPCS)

GCPPCS

 

There is an ever-growing demand for trained and certified Good Clinical Practice (GCP) professionals in the clinical research arena both in academia and in industry. Setting up an uniform system to achieve the desired competence standard using internationally accepted best practice for ‘Assessment’ and ‘Certification’ is the key to addressing this unmet need.

To this end, a Certification Scheme for GCP professionals based on the International ‘Personnel Certification’ standard (ISO 17024:2012) has been developed by CDSA-THSTI.

The GCP professional certification scheme has  two aspects – a system of accreditation of Training Institutions to ensure standardised, high-quality GCP training and  GCP Professionals Certification (by Third-Party Certification) to promote certification of professionals both within the country and across the globe.

GCPPCS is owned by the Clinical Development Services Agency (CDSA)-Translational Health Science & Technology Institute (THSTI). THSTI is an autonomous institution under the Department of Biotechnology, Ministry of Science & Technology, Government of India. CDSA-THSTI as Scheme Owner,  has the Steering Committee, Technical Committee and Assessment Committee to draft, review and approve the relevant documents and  effective implementation of the Scheme.  These committees are comprised of multiple stakeholders for example subject and process experts with representatives from ministries, regulator, government agencies, industry, academia, accreditation body, certification body, training institutions and civil society organisations.

The following documents are available for the GCPPCS.

A) Overview

B) Governing Structure

C) GCP Professional Certification

D) GCP Training Institute Accreditation

E) General Documents

GCPPCS Forms:

    1. Personnel Certification Body (PrCB) – Documentation Review cum Office Assessment Report 
    2. Personal Certification Body (PrCB) – Application Form for Provisional Approval
    3. Training Institution (TI) – Application Form for Provisional Approval
    4. Training Institution (TI) – Documentation Review cum Office Assessment Report

For further information: gcppcs.cdsa@thsti.res.in