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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
Why is GCP training so important?
Initial Process of review and registration1. The provider details are captured on an excel spreadsheet maintained by
the SACRA administrator2. 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 applicable5. 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 2Beginner training: General points minimum 6, Ethics
points minimum 2Refresher 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 ResourceGeneric 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 developmentDetailed curriculum is not required but instead,
information on how training needs are established and how curriculum is developed accordingly.
Technology and tools usedStatement of what technology is used in training and in
the process of development of material & how it is delivered?
QMSA 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 Items Yes No Comment
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 toolItems Yes No Comment
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 SematimbaSACRA Coordinator
011 024 2678083 6308612