Profiling the CRA. Phase 2: Aimed CRAs or clinical site monitors.

SACRA seeks your participation in a Study to Profile the South African Clinical Research Associate: Link: https://gustav4.typeform.com/to/Xj8DRr

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 2 of the study as per instructions below in this Email:2

Phase 2, which is aimed directly at the Clinical Research Associates (CRAs) or clinical site monitors.

Phase 2 Questionnaire is found at the the link:

https://gustav4.typeform.com/to/Xj8DRr

To: The Clinical Research Associate / Clinical Site Monitor

RE: Request to Participate in Postgraduate Research Study that will be presented at the 2018 SACRA Conference in September.

I am an MPharm student in the Department of Pharmacy at the Sefako Makgatho Health Sciences University (SMU), formerly known as Medunsa. The title of my Master’s degree study is:

“Profiling the Clinical Research Associate in South Africa”

The second phase of the data collection for my research includes Phase 2, which is aimed directly to the CRAs or clinical site monitors.

I wish to request the following from you:

1. To participate in Phase 2 of the study as a CRA or Monitor, and

2. To consider distributing information regarding this Phase 2 of my research project to other CRAs in South Africa (i.e. friends or colleagues), for them to consider their voluntary participation.

[During the third phase of my study I hope to compile a profile of the Clinical Research Associate in South Africa.]

If you agree to participate in Phase 2 of the study, please refer to the relevant section below. In addition, should you be willing to distribute information to your fellow CRAs, please feel free to forward this email to as many of your CRA colleagues as possible.

Participation in Phase 2: CRAs / Clinical Site Monitors:

Questionnaire link:

https://gustav4.typeform.com/to/Xj8DRr

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

Therefore, the following documents have been attached to this email message:

· 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.

It should take you about 20-30 minutes to complete.

Please note that Typeform® is best suited to be accessed via Internet Explorer®. You will also notice the following status bar, which will indicate your progress when completing the questionnaire. Please ensure that you respond to all of the questions:The Phase 2 Questionnaire may be accessed via the following link: https://gustav4.typeform.com/to/Xj8DRr

I trust that you will find the above information to be in order. Please feel free to contact me or one of my supervisors (via the contact details displayed below), should you require any additional information in this regard.

Yours faithfully,

Gustav Schellack

Postgraduate student: MPharm degree programme

Gustav Schellack

Gustav.Schellack@ppdi.com/ gustav.schellack@gmail.com

Tel: (012) 521 4567/4080

Fax: (012) 521 3992

Cell: 060 970 5877 (Gustav)

Cc: Prof Beverley Summers (Study supervisor)

Prof Lesley Burgess (Study co-supervisor)

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P.O Box 218

Medunsa

0204

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