GCP Sub-Committee of Industry Stakeholders Guide to review of GCP course for CPD accreditation 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)

Application form: Minimum requirements Good quality GCP Training GCP Course Facilitators Training Providers

Why is GCP training so important?

Initial Process of review and registration 1.The provider details are captured on an excel spreadsheet maintained by the SACRA administrator 2.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 3.The application is reviewed. 4.The reviewer will submit any questions to the applicant if applicable 5.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 6.An appeals process will be in place. This appeal application will be addressed in a committee meeting.

Problem with this process  Committee not a ETQA or body recognized to accredit  Members of committee have potential for COI

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

Minimum requirements for training providers 1.OPERATIONAL PLAN: A generic statement on the organisation / departments’ objectives or goals. 2.HUMAN RESOURCES 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.

Minimum requirements for facilitators  Qualified facilitators: by experience and qualification – min 2 years experience  Qualification refers to but is not limited to adequate medical, pharmaceutical and/ scientific qualification  Experience refers to but is not limited to at least 2 years of active exposure in GCP environment of clinical research.  Facilitators should either have formal trainer qualifications or at least 2 years experience in lecturing/teaching/training

Minimum requirements for GCP courses  Course curriculum outline / agenda Curriculum to incorporate South African guidelines as well as applicable international guidelines  Learning Plan/Outcomes  Beginner training: minimum of 8 hours of training time (excluding breaks)  Refresher training: minimum of 4 hours of training time (excluding breaks)  CPD accreditation CEU (Continued Educational Units) Level 2 Beginner training: General points minimum 6, Ethics points minimum 2 Refresher training: General points minimum 4, Ethics points minimum 1.

GCP course cont:  Methods of formative and summative assessments 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.)

Section 3: Application information  Operational Plan cont. Curriculum development Detailed curriculum is not required but instead, information on how training needs are established and how curriculum is developed accordingly. Technology and tools used Statement of what technology is used in training and in the process of development of material & how it is delivered? 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?

Section 3: Application information  Facilitators of learning  Evidence of qualification & C.V & Evidence of training qualification  The Facilitator can match their qualification with their experience and C.V: Substantiate your  qualification to do training if facilitator does not have a Science degree.  Substantiate the relevance of qualification to be a GCP Trainer and your highest Tertiary training.  All trainer/ facilitator documents to be provided

Section 3: Application information  Course Information  Different types of courses offered and Modules providing the module information.  Objectives and outcome to be provided.  Objective: what the participant should be able to do at the end of this study? Eg. The participant should be able to describe an adverse serious event  Course content should incorporate South African- GCP as well as international GCP

Section 3: Application information  Course Content Evaluation  The applicant conducts a review of each course module to confirm alignment with the applicable local and international guidelines.  Each course should have a learning plan or list of learning objectives

Section 3: Application information  Other application questions relate to  Practical exercises  Teaching methodologies  Course customization  Learning outcomes communication  Learning and assessment processes

Application supporting documents  Documentary evidence as indicated in the form  Operational Plan  Facilitator documents: CV, qualification, relevant training certificates  Course outline / agenda  Course /module learning plan  Course and facilitator evaluation template  Current course CPD accreditation details  GCP certificate template

Reviewer checklist tool ItemsYesNoComment 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

Reviewer checklist tool ItemsYesNoComment 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