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Study design and protocol development

The starting point for a good study is developing a good research question and applicable design. Thereafter it is important to write a good protocol or recipe to follow. There are many tools and advisory websites to support the researcher to achieve this. The right hand panel provides you with several useful links that are considered to be user friendly.

In addition, there are international reporting guidelines for every type of research design and it is imperative to ensure that if you are to report on an aspect of a study, you must have included it in the protocol at the outset. We therefore recommend you read the relevant reporting guidelines before you start to write your protocol. The aim of providing protocol writing support to UCT clinical researchers is twofold:

  1. To ensure researchers are aware of the minimum requirements for writing a protocol for a research project.
  2. To ensure all projects have a clearly defined protocol that complies with South African GCP requirements and the relevant regulations which may include, but are not limited to, those of the UCT Human Research Ethics Committee and the South African Medicines Control Council (MCC ).

Templates for clinical trials of Investigational Medicinal Products [IMPs] and non-IMP studies are provided, together with some useful advice for the process of writing a protocol.