Society for Clinical Research Sites



Guidance for TransCelerate – Informed Consent Logs Version: 1.0 - 2015 Informed Consent Logs Background: The two Informed Consent Logs (Protocol Level Informed Consent Form (ICF) Tracking Log and Site Level ICF Tracking Log) were created to provide a common mechanism for sites to facilitate a more meaningful and well informed discussion with patients about changes to the informed consent forms (ICFs) provided by sponsors.These documents provide a way to share and track significant changes to the Informed Consent Form, between the study sponsor and the participating site and allow for consistent documentation of the changes for site staff, visiting sponsors, and potential auditors Contents: The Protocol Level ICF Tracking Log is for use by the sponsor to track required/requested significant changes at the Protocol (sponsor) level. Significant change refers to the changes of mandatory language of the ICF, as identified by the Sponsor. Examples of mandatory language sections may include enrollment/randomization, risks and benefits, sample management, data privacy or future use of data.The Site Level ICF Tracking Log is for use by the site to track required/requested significant changes to the Protocol level ICFTransCelerate Members companies may accept and implement the Informed Consent Logs, but are not required to do so.The Informed Consent Logs are not intended to replace any ICH/GCP or local ethics committee or IRB regulations, policies, or procedures regarding the informed consent process for study subjects.Use: There are two forms associated with the Informed Consent Logs:The logs are intended to be completed each time an ICF change occurs. Rationale for the revision, significant summary of the change will include enough information to provide any reviewer of the document a sufficient overview of the ICF changes to date.Noted below are examples of the content to be completed for each field:Protocol Level ICF Tracking LogICF Sponsor Date/Version – version date and number of the sponsor provided ICF document ICF Type – Specifies which consent has been changed – ie: Main, PGx, AddendumRationale for Revision – Provides reasoning for ICF revision (e.g. a safety event)Summary of Significant Changes-a summary of the significant changes made at the sponsor/ country level to the ICFNotes-free text field for site useSite Level ICF Tracking LogICF Sponsor Date/Version – version date and number of the sponsor provided ICF document No Change – place a ” X” in the column if no changes were made at the site levelRationale for Revision – the justification or reasoning behind an ICF revision (e.g. a safety event)Summary of Significant Changes – a summary of the information being updated or changed within the sponsor ICFApproval date – the latest approval date from the IRB/EC/MOH/HA with jurisdiction over the site level ICFPlease note that examples of specific changes, rationale, and information have been noted below: The Informed Consent Logs can be accessed on the TransCelerate Website under the Site Qualifications and Training Initiative. This document is intended to be updated on an ongoing basis as applicable and maintained at the site. If you experience software compatibility issues completing TransCelerate forms:You may check your adobe software version. The minimum system requirement is adobe reader. We advise you to download the newest version of adobe reader, which can be found for free on the adobe website. Please click on the link below and follow steps 1-3. If for any reason the newest version did not download correctly- please uninstall the current version you have on your computer and reinstall the newest version. If you have issues accessing/or completing the form please contact the individual/member sponsor who requested the form. ................
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