HPCSA_14 Feb 2011
Transcript of HPCSA_14 Feb 2011
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GCP Sub-Committee of Industry
Stakeholders
Guide to review of GCP course for CPD
accreditation
9Feb10
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BACKGROUND
� The GCP sub-committee of the National Health
Research Ethics Council (NHREC) was formed in 2009
following the perceived industry need to standardizeGCP 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.
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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 contentdid not clearly reflect an adequate incorporation of
South African guidelines and terminology.
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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
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GCP Committee The GCP sub committees mandate is as follows:
To identify the minimum curriculum requirements for GCPtraining providers
To set up and manage a database of GCP course providersvia the SACRA website
To communicate with stakeholders/ providers the local GCPtrai
ning provider requirements and the process of reviewand 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 aSector Education Training Authority (SETA)
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Application form: Minimum requirements
Good quality GCP Training
GCPCourse
Facilitators
TrainingProviders
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Why is GCP training
so important?
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Initial Process of review and registration1. 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 thecourse 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, theprovider will receive a registration number that will need to be reflectedon the GCP certificate
6. An appeals process will be in place. This appeal application will beaddressed in a committee meeting.
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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.
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Application Process
Transferred committee review process to HPCSA CPDaccreditors:
Minimum requirements
Application form
Reviewer checklist
Guideline for submission
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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 areselected;
Qualifications required, permanent or temporary,
how the facilitator is selected etc.
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Minimum requirements for facilitators Qualified facilitators: by experience and
qualification min 2 years experience
Qualification refers to but is not limited toadequate medical, pharmaceutical and/scientific qualification
Experience refers to but is not limited to at least2 years of active exposure in GCP environmentof clinical research.
Facilitators should either have formal trainerqualifications or at least 2 years experience inlecturing/teaching/training
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Minimum requirements for GCP courses Course curriculum outline / agenda
Curriculum to incorporate South African guidelines as well asapplicable international guidelines
Learning Plan/Outcomes Beginner training: minimum of 8 hours of training time (excludingbreaks)
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 2
Refresher training: General points minimum 4, Ethics pointsminimum 1.
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GCP course cont:
Methods of formative and summative assessments
� Formative assessments for example quiz, Q&A, case studies, roleplay, etc. Minimum 2 assessments.
� Summative test to have a minimum pass rate of 70%
Methods of evaluation of training course, that is, delegateevaluation of the course content and facilitator
GCP certificate
� Full name of delegate, Course type (B
eginner/Refresher), Date of course, Test score achievement, CPD accreditation number, levelof activity and CEU points, HPCSA/relevant professional boardregistration number, Signature and name of trainer
� GCP refresher training will be done on a 3 yearly basis
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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 concisestatement on how they are selected;
(qualifications required, permanent or temporary, how the facilitator isselected etc.)
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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?
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Section 3: Application information Facilitators of learning
E vidence of qualification & C.V & E vidence of trainingqualification
The Facilitator can match their qualification with their experience and C.V: Substantiate your
qualification to do training if facilitator does not have aScience degree.
Substantiate the relevance of qualification to be a GCPTrainer and your highest Tertiary training.
All trainer/ facilitator documents to be provided
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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?
E g. The participant should be able to describe an adverse serious event
Course content should incorporate South African- GCP as
well as international GCP
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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
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Section 3: Application information
Other application questions relate to
Practical exercises
Teaching methodologies
Course customization
Learning outcomes communication
Learning and assessment processes
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Application supporting documents Documentary evidence as indicated in the form
Operational Plan
Facilitator documents: CV, qualification, relevant trainingcertificates
Course outline / agenda
Course /module learning plan
Course and facilitator evaluation template
Current course CPD accreditation details
GCP certificate template
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Reviewer checklist toolItems 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 availableIs local and international guidelines
covered in content
Course duration appropriate for
course type
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Reviewer checklist tool
Items 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 asspecified in the
application form
Training provider meets
all criteria and can
be approved and
registered
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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 accreditoror 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 CPDaccreditation 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 froma 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 minimumrequirements. 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 andmeet minimum requirements to receive a single CPD accreditation. Only one GCP certificate indicatingrefresher or beginner GCP training should be generated after the delegate has attended all requiredmodules
Short GCP training activities that are not formally submitted as part of Beginner/Refresher training programswill NOT receive CPD accreditation.
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Questions?
Contact information:
Barbara SematimbaSACRA Coordinator
011 024 2678