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Profiling the CRA: Phase 1: Employers & Managers of CRAs.

SACRA seeks your participation in a Study to Profile the South African Clinical Research Associate: Link: https://gustav4.typeform.com/to/H2EZXt

Emailer 1: Employers and CRMs

Phase 1, is aimed at the employers of Clinical Research Associates (CRAs) or Clinical Site Monitors.

Phase 2, is aimed at CRAs or Clinical Site Monitors directly.

Phase 3, is aimed at compiling a profile of the Clinical Research Associate in South Africa.

SACRA requests you participate in Phase 1 of the study as per instructions below in this Email:1

Phase 1, which is aimed at the Employers of Clinical Research Associates (CRAs) or clinical site monitors, and

If you agree to participate in Phase 1 of the study, please refer to the relevant section below. In addition, should you be willing to distribute information to your CRAs, please confirm this via return email and I will send you the necessary information to be communicated to your CRAs.

See details of the phase 1 in the information following:

Participation in Phase 1: Aimed at the Employers of Clinical Research Associates (CRAs) or clinical site monitors.

Questionnaire to this phase will be accessed via the following link: https://gustav4.typeform.com/to/H2EZXt

You are hereby requested to consider your voluntary and anonymous participation in this phase of the research study.

The following documents have been attached to this message for your perusal in order to confirm the

· A brief study presentation (slide show)

· A copy of the relevant ethics approval notice for the study, as approved by the Sefako Makgatho Health Sciences University Research Ethics Committee, or SMUREC (reference number: SMUREC/H/188/2015: PG)

· The Informed Consent Form and Study Information Leaflet.

The Questionnaire may be accessed via an online platform, namely Typeform®, and the informed consent is obtained via this platform.

The Phase 1 Questionnaire may be accessed via the following link:

https://gustav4.typeform.com/to/H2EZXt

It should take you about 10-15 minutes to complete.

Kindly complete this questionnaire on behalf of your entire South African operation.

Thank you.

Gustav Schellack

Gustav.Schellack@ppdi.com

Postgraduate student: MPharm degree programme

Tel: (012) 521 4567/4080

Fax: (012) 521 3992

Email: gustav.schellack@gmail.com & Gustav.Schellack@ppdi.com

Cell: 060 970 5877 (Gustav)

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