The GCP subcommittee of industry stakeholders would like to provide you with a status update on the process of review of GCP training providers:

                                                                                                                          Information Memo

Good Clinical Practice Training in South Africa

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. There were a number of reasons for this: 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. An industry stakeholders meeting was held on 23 January 2009 which included attendance by the representatives of the NHREC. At this meeting, the various stakeholders presented the problems experienced and discussed the minimum requirements for GCP training. The NHREC resolved that a GCP sub-committee be formed under the umbrella of the South African Clinical Research Association (SACRA). This committee’s activity will be overseen by the NHREC. The committee was voted in by industry and will serve the function of review and endorsement of GCP training providers in South Africa on behalf of the NHREC.

A meeting was held on 5 June 2009 at the Midrand Conference Centre to determine the voting process for the committee formation including a working plan guidance framework with an expected target date for all provider reviews to be completed by January 2010. Nominations for and voting of the committee members were administered through the SACRA website. The voting process was completed by July 2009. The following industry representatives were elected to serve on the committee:

Elsabe de Kock: Retrasol

Marzelle Haskins: PharmaEthics, Committee Chairperson (resigned)

Mohlabane Majoe: Pfizer pharmaceuticals

Prof. Lesley Burgess: TREAD Research, MCC Clinical Trial Committee

Savi Chetty- Tulsee: AGCP, SCT Consulting, Committee Chairperson

Marijke Geldenhuys: SATVI/UCT, Committee Vice Chairperson

Laurette Bonthuys: MCC - Inspectorate

Prof Keymanthri Moodley: Stellenbosch University (resigned)

Fathima Amod: Independent

Siza Mphele: ClinDev

Uttam Govind: University KZN

Mary-Ann Richardson: ACRO

The committee members served as volunteers and were not paid for their activities. They were however be reimbursed for costs incurred in conducting the relevant committee activities.  All potential conflict of interest of the committee members had been declared.  Two members of the committee have since resigned.

The objectives of the committee:

1. Review the framework of minimum requirement for GCP training submitted to the NHREC. Make recommendations or confirm committee’s agreement to the NHREC.
2. Create/ define the application process for training providers
3. Define a registration process for training providers
4. Establish processes for the review of the training curriculum
5. Establish processes for the review of the trainers
6. Establish a process for continued review
7. Establish an appeals process
8. Communicate with the NHREC, MCC and EC in matters relevant to GCP training

Committee Activities:

The NHREC communicated with the committee in a letter dated 28Oct09 that the council had resolved that all GCP training providers should proceed toward accreditation with a relevant Sector Education and Training Authority (SETA) under the South African Qualifications Authority (SAQA). This accreditation process is to be completed by year 2011. More information on SAQA and the SETA can be found on the SAQA website www.saqa.org

The committee responded in a face to face meeting with a representative of the council that the 2011 target date was not practically feasible, is a cost limiting requirement, will hinder “one man” training provider functions as well as external GCP training offered by international sponsors in funded studies conducted in South Africa. The committee proposed a 5-10 year plan for providers to plan toward accreditation. As an interim measure, the committee will serve to complete the process of conducting a review of the training providers and providing feedback on the prescribed minimum training requirements. The committee will maintain a database of training providers and on successful review of the training provider, a registration number will be provided to be included into the GCP certificate. This will be a confirmation to Ethics Committees, Medicines Control Council and other related organisations who will review the certificate that the training provider has been endorsed.

The registration process for training providers had been initiated on the SACRA website (www.sacraza.com). The registration is on an open section of the website ensuring access to all training providers. The registration form captures basic information about the provider.

The registered providers were contacted to submit a completed application for review. The completed application and supporting documents, including a review fee payment was to be delivered to the PharmaEthics offices in Centurion, South Africa. The initial review fee was R4500 per application. It was expected that a bulk review will be completed by the committee to reduce travel costs and to expedite the review process. The financial management of the committee’s function will be administered by SACRA.

A summary of the process of review and registration of GCP training providers was as follows:

1. Provider registers on the SACRA website.
2. The provider details are captured on a database maintained by the SACRA administrator
3. The provider receives a request to complete the application form and provide the applicable documentation to allow for the review of the course content, training provider systems and trainers. The application documents will be posted on the SACRA website. The application process will be initiated at the beginning of March 2010
4. The application is reviewed.
5. The reviewer will submit any questions to the applicant if applicable
6. Once the reviewer is satisfied all required conditions are met, the provider will receive a registration number that will need to be reflected on the GCP certificate
7. An appeals process will be in place in the event that an applicant does not accept the decision of the reviewer. This appeal application will be addressed in a committee meeting.
8. The provider will be required to submit annual reports for continued approval. 

 The committee also explored avenues of in an effort to streamline the process toward SAQA accreditation of GCP training providers. An application was submitted to the Health Professions Council of South Africa (HPCSA) with the written support of the NHREC to review and accredit the GCP training providers on the 28Jul10. The HPCSA is an ETQA (Education and Qualifications Authority) of SAQA.  At the HPCSA board meeting on the 13 October 2010, it was resolved that the standard requirement for GCP training courses as determined by industry will be incorporated into the CPD (Continuing Professional Development) accreditation application. This decision was communicated to the committee on 01 Dec10.

In the meanwhile the committee convened its first meeting on 21Oct10 reviewing eleven applications. Having evaluated 11 applications at the meeting held on 21Oct10, the committee was confident that the information requested and supplied was adequate to evaluate the training provider and course(s) offered. The committee decided that further guidance on the operational and learning plan information requirements should be provided to the training providers to enable them to provide information without concerns of breach of intellectual property.  An additional meeting of the sub-committee was held on 6 December 2010 to review the responses of the applicants from the meeting of 21Oct10. No new applications were reviewed.

A meeting with the HPCSA was held on 7 December 2010. At this meeting the HPCSA confirmed that the review of courses will now be the responsibility of the HPCSA approved accreditors. The 11 applicants reviewed by the committee will be required to submit for annual CPD accreditation to the approved accreditor office of their choice and the CPD review is expected to include the requirements as set forth by the committee. Each applicant will be required to complete a CPD 2A form as well as the application form developed by the committee. The cost of the review will not be more than that of the standard annual CPD accreditation application costs charged by the accreditor, as all courses are capped for CPD points regardless of the length

The HPCSA invited the committee to address the accreditors at a national forum meeting on 14Feb11 to provide guidance on the review process. The committee also extended an offer of support to assist the accreditors in this transition process. The 11 applicants reviewed on 21Oct10 received a reimbursement after the costs of the review process was accounted for. The HPCSA confirmed that the accreditors will provide an annual report of their accreditation activities and will therefore be able to monitor the accreditors on an ongoing basis.

It was initially planned that a unique number will be issued for each GCP training provider to confirm that the provider has been reviewed by the sub-committee. This will no longer be the case. The CPD accreditation number allocated for the course that will be offered by the training provider will attest that the provider met the industry requirements. A list of all GCP providers that have been through the GCP stakeholder committee review, will be sent to the MCC/IRBs.

The committee also addressed e-learning in South Africa and drafted a checklist of attributes of e-learning that should ensure optimal learning and assuage the concerns of stakeholders. The checklist was submitted to the NHREC for approval. With approval from the NHREC, the e-learning formats can be submitted to the HPCSA accreditors for CPD accreditation.  

Summary information to GCP learners:

As of January 2011, all GCP training providers in South Africa will be subject to a process of review to ensure that the providers meet the requirements as set forth by industry. These requirements were set to ensure a consistent and high standard of GCP curriculum execution within South Africa. The training providers are to submit applications for accreditation of their GCP courses to approved HPCSA accreditors. The accreditors will review the application against the standard requirements and allocate CPD accreditation numbers and points for the course(s). Kindly ensure that you check with the GCP training provider if the course has been accredited by an approved HPCSA accreditor prior to enrolling in the course. Your GCP certificate may not be accepted by the Medicines Control Council or Ethics Committee if it is not issued by an accredited provider