Discussing the study protocol part 2

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Concensus Statement

ADVERSE EVENTS/ ADVERSE DRUG REACTION

When drafting a study protocol it is important that the team has an understanding of the difference between an adverse event and a adverse drug reaction. There is room within the protocol to provide guidance and differentiate between the two.

Local reporting timelines for adverse events and serious adverse events will need to be considered, depending on the type of study.

 A few examples of local guidance on adverse event reporting which one can refer to are listed below .

  1. Medicines Control Council , Reporting Adverse Drug Reactions in South Africa (see resource list on this webpage for an electronic copy)

  2. Unanticipated Problems Involving Risks to Research Participants and Others Including Adverse Events Standard Operating Procedure, Human Research Ethics Committee, Faculty of Health Sciences, University of Cape Town, Last Revised January 2013 (see resource list on this webpage for an electronic copy)

 The protocol should also clearly define who will do the reporting. It is can be either the Clinical Research Associate, the Sponsor or the site (in the case of investigator lead studies).

 USE AVAILABLE GUIDANCE DOCUMENTS

Initially when working with a study protocol aim to draft your document according to standardized templates and checklists.

Examples mentioned during the disscussion were the SPIRIT guidelines for clinical trial protocols. These guidelines have been incorporated into the new UK Health Research Authority protocol guidance template (see resource list on this webpage for an electronic copy).  

This document known as the CTIMP is open for comment until May 2015.

PRISMA-P is a new addition  to the guidance documents available for systematic reviews and meta-analyses protocols 

 DOCUMENT VERSION CONTROLLING

“If your protocol or document has been changed it needs to have a new version” . Ideally the format of version controlling used should be provided in a standard operating procedure to the team (this will serve to avoid errors across teams)

CLOSING STATEMENT

Overall the group felt that both “The Study Protocol Part 1 & Part 2” should be completed by all members of staff within a research team.