GOOD CLINICAL PRACTICE PROFESSIONAL CERTIFICATION SCHEME (GCPPCS)

ABOUT 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) is being developed by CDSA-THSTI.

The GCP professional certification scheme will have 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 will be 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 constituted  Steering Committee, Technical Committee and Assessment Committee to draft, review and approve the relevant documents (see below) and also for  effective implementation of the Scheme.  These committees comprise 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 developed for the GCPPCS, are now available for public comments.

A) GCP Professional Certification

        1. Minimum Standard of Competence
        2. System for provisional approval of Personnel Certification Bodies
        3. Certification process

B)     GCP Training Institute Accreditation

        1. Criteria for provisional approval of GCP Training Institutions
        2. Assessment process for the provisional approval of Training Institutions

C)     General Documents

        1. Rules for use of GCPPCS Certification Mark by approved Personnel Certification Bodies (PrCB) and Training Institutions (TI)

 

PUBLIC COMMENTS (Deadline: June 30, 2020)

The above-mentioned documents are available for public comments. Interested individuals are invited to share their views/suggestions by clicking here . Any inputs received after the deadline will not be considered.

Email: gcppcs.cdsa@thsti.res.in