Transcript Year End Meeting

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:
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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
Facilitators
Training
Providers
GCP
Course
Good quality GCP Training
Why is GCP training
so important?
Initial Process of review and registration
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The provider details are captured on an excel spreadsheet maintained by
the SACRA administrator
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 is reviewed.
The reviewer will submit any questions to the applicant if applicable
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
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
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Qualified facilitators: by experience and
qualification – min 2 years experience
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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
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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%
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Methods of evaluation of training course, that is, delegate
evaluation of the course content and facilitator
GCP certificate
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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
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Documentary evidence as indicated in the form
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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
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
Yes
No
Comment
Reviewer checklist tool
Items
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
Yes
No
Comment
SUMMARY
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Provider registers on the SACRA website. This is simply to have a complete list of GCP Training Providers in
South Africa
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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.
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The CPD accreditor will review the application form and associated documents using the checklist as a guide
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The CPD accreditor will submit any questions to the applicant if applicable
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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
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Ethics committees and MCC will only accept GCP certificates with a CPD accreditation number obtained from
a HPCSA CPD accreditor
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The provider will be required to make yearly applications as per the normal CPD accreditation process.
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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)
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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
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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
[email protected]