Professional Documents
Culture Documents
9Feb10
BACKGROUND
The GCP sub-committee of the National Health Research Ethics Council (NHREC) was formed in 2009 following the perceived industry need to standardize GCP training in South Africa. During the course of 2008 it emerged that various ethics committees were not accepting GCP certificates issued by some training providers.
BACKGROUND (CONT)
Some of the reasons why some GCP certificates were not accepted: The training was provided by an unknown provider to the ethics committee; There was no post test conducted; the learning was e-based or that the course content did not clearly reflect an adequate incorporation of South African guidelines and terminology.
GCP SUB-COMMITTEE
GCP Sub-Committee of the NHREC was established mid 2009 following a nomination and industry voting through SACRA. Current Committee Members:
Savi Chetty-Tulsee: Training Provider, Independent Fathima Amod: Training Provider, Independent Elsabe de Kock: Training Provider, Independent Mohlabane Majoe: Pharma Prof. Lesley Burgess: TREAD Research, MCC Clinical Trial Committee Marijke Geldenhuys: Academic Laurette Bonthuys: Regulatory/MCC Inspectorate Siza Mphele: CRO Uttam Govind: Academic Mary-Ann Richardson: CRO
GCP Committee
The GCP sub committee s mandate is as follows:
To identify the minimum curriculum requirements for GCP training providers To set up and manage a database of GCP course providers via the SACRA website To communicate with stakeholders/ providers the local GCP training provider requirements and the process of review and registration To review the course overview, review provider trainer experience and qualifications To communicate to the stakeholders/ providers the NHREC requirement for training providers to be accredited with a Sector Education Training Authority (SETA)
Facilitators
Training Providers
GCP Course
Solution
Application to the HPCSA board to include this review process into the current CPD accreditation process Independent body Annual submission to allow for change in provider and course material and courses.
Application Process
Transferred committee review process to HPCSA CPD accreditors: Minimum requirements Application form Reviewer checklist Guideline for submission
Formative assessments for example quiz, Q&A, case studies, role play, etc. Minimum 2 assessments. Summative test to have a minimum pass rate of 70%
Methods of evaluation of training course, that is, delegate evaluation of the course content and facilitator GCP certificate
Full name of delegate, Course type (Beginner/Refresher), Date of course, Test score achievement, CPD accreditation number, level of activity and CEU points, HPCSA/relevant professional board registration number, Signature and name of trainer GCP refresher training will be done on a 3 yearly basis
Application form
Section 2: details of the training provider Section 3: Application information
Operational plan
A generic statement on the organisation/departments objectives or goals. Human Resource
Generic information on how trainers are recruited. General concise statement on how they are selected; (qualifications required, permanent or temporary, how the facilitator is selected etc.)
QMS
A statement of policies that govern and support the conduct of training. What systems developed ensure the quality of the delivery of your training and the content of training?
Course content should incorporate South African- GCP as well as international GCP
Registration on SACRA database Operational plan explains the training operation of the organization Training facilitators have the relevant experience and qualification Learning plan available Agenda/ course program available Is local and international guidelines covered in content Course duration appropriate for course type
CPD accreditation available Methods of evaluating learners are provided and acceptable Methods of evaluating course and facilitator is available GCP certificate reflects the criteria as specified in the application form Training provider meets all criteria and can be approved and registered
SUMMARY
Provider registers on the SACRA website. This is simply to have a complete list of GCP Training Providers in South Africa The provider obtains the GCP training CPD application forms either directly from the HPCSA CPD accreditor or from SACRA website and submits it to a HPCSA CPD accreditor. The CPD accreditor will review the application form and associated documents using the checklist as a guide The CPD accreditor will submit any questions to the applicant if applicable Once the CPD accreditor is satisfied that all required conditions are met, the provider will receive a CPD accreditation number that will need to be reflected on the GCP certificate Ethics committees and MCC will only accept GCP certificates with a CPD accreditation number obtained from a HPCSA CPD accreditor The provider will be required to make yearly applications as per the normal CPD accreditation process. GCP beginner and refresher courses must be labeled as such on the certificate and must meet minimum requirements. Courses of longer duration will still receive the same number of CPD points (capped) Short/modular training provided at various intervals during the year must be outlined in the application and meet minimum requirements to receive a single CPD accreditation. Only one GCP certificate indicating refresher or beginner GCP training should be generated after the delegate has attended all required modules Short GCP training activities that are not formally submitted as part of Beginner/Refresher training programs will NOT receive CPD accreditation.
Questions? Contact information: Barbara Sematimba SACRA Coordinator 011 024 2678 083 6308612 barbara@sacraza.com