Amendments to protocols approved by ISAC

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During the course of some studies, it may become necessary to deviate from a protocol which has been approved by ISAC. Researchers intending to deviate from an ISAC approved protocol must clearly document all intended amendments. Amendments may require reassessment by the ISAC based on the following principals: Major amendments should be submitted

Minor amendments need not be submitted (but must still be documented by the applicant and should normally be mentioned at the publication stage)

In cases of uncertainty, the applicant should contact the ISAC secretariat for advice quoting the original reference number and providing a brief explanation of the nature of the amendment(s) and underlying reason(s).

Major Amendments

We consider an amendment as major if it substantially changes the study design or analysis plan of the proposed research. An amendment should be considered major if it involves the following (although this is not necessarily an exhaustive list):

  • A change to the primary hypothesis being tested in the research
  • A change to the design of the study
  • Additional outcomes or exposures unrelated to the main focus of the approved study*
  • Non-trivial changes to the analysis strategy
  • Change of principal investigator
  • Use of additional linkages to other databases
  • Any new proposal involving contact with health professionals or patients or change in regard to such matters

* N.B. extensive changes in this respect will require a new protocol rather than an amendment - if in doubt please consult the Secretariat

Minor Amendments

Examples of amendments which can generally be considered minor include the following:

  • Change of personnel other than the principal investigator
  • A change to the definition of the study population, providing the change is mentioned and justified in the paper/output [NB previously major]
  • Extension of the time period in relation to defining the study population
  • Changes to the definitions of outcomes or exposures of interest, providing the change is mentioned and justified in the paper/output [NB previously major]
  • Limited additional analysis suggested by unexpected findings, provided these are clearly presented as post-hoc
  • Additional methods to further control for confounding or sensitivity analysis provided these are to be reported as secondary to the main findings

To submit an amendment of protocol to the ISAC, please submit the following documents to the ISAC mailbox

  1. A covering letter providing justification for the request
  2. A completed and, if necessary, updated application form with all changes highlighted
  3. The updated protocol document containing the heading 'Amendment' at the end of it. Please include all amendments to the protocol under this heading. No other changes should be made to the already approved document.