Case Study Protocol

When and How to Use a Case Study Protocol

Case study investigators need to develop their protocols in at least two stages: a preliminary stage [Page 85]and a final stage. The preliminary stage occurs after the case(s) to be studied have been screened and selected and after any pilot case study has been conducted. Those earlier steps may themselves have been the subject of formal documentation and procedures, but the steps should have been completed before drafting the preliminary case study protocol.

The preliminary protocol, though still reflecting tentative plans and ideas, should nevertheless be contained in a formal document. Case study investigators will need this document as a central part of their submission to their institutional review board (IRB). The IRB will review the protocol in approving the entire case study research project. Because the IRB will ascertain whether the planned case study will satisfactorily follow all of the necessary procedures for protecting the human subjects, IRB approval is mandatory before any research can proceed (not discussed here are the related documents that investigators will have to submit to their IRB).

The IRB's review may result in changes to the case study protocol. The version meeting with their final approval then represents the final stage of the protocol. This final protocol now contains the procedures to be followed in conducting the actual case study.

The preliminary protocol may have been developed alone, especially if the case study is to be conducted by a single investigator. However, if the planned case study is to involve more than a single investigator, and especially if others are to serve as part of the case study's field teams, the preliminary protocol should have been jointly produced by all these people. Although the lead investigator may still draft the bulk of the protocol, the others need to understand the protocol thoroughly. Such understanding best takes place if all team members have had an opportunity to contribute to its development.

Such familiarity with the preliminary protocol will be carried into the formal training process that then takes place with the final protocol. When two or more people are to be involved in doing the case study, the preferred case study training assumes the form of a working seminar, with participants discussing the contents of the protocol, their implications in relation to the case study's line of inquiry, and the relevant evidence bearing on the line of inquiry. The training process therefore becomes the opportunity for all of a case study's investigators and field team members to develop the same collective understanding of the inquiry to be undertaken. Naturally, if the case study has only a single investigator, the training will assume the form of a self-study.

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