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Informed consent form (ICF)

ICF stands for Informed Consent Form—a document that provides essential information about a clinical trial to potential participants to ensure their complete understanding of the research nature, the risks and potential benefits involved, and their rights as participants.

In CTMS, you can track the distribution, collection, and status of ICFs, ensuring proper documentation and completion of all steps related to informed consent throughout the trial process. The ICF tracking occurs via the following modules:

  • ICF listing: record all master and site ICFs whose completion you want to trace via the tracking log; maintain main details of ICFs and cross-reference site ICFs to their respective master ones.

  • ICF tracking log setting: select the ICF tracking log template for a study and maintain its versioning.

  • ICF tracking log: add and maintain ICF tracking records to trace ICF completion by study subjects.

  • ICF tracking summary: analyze an exhaustive report on ICF completion by subjects.

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