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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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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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

083 [email protected]

Documents

HPCSA_14 Feb 2011