A protocol deviation is any noncompliance with the clinical trial protocol, Good Clinical Practice (GCP), or protocol-specific Manual of Procedures requirements. The noncompliance may be either on the part of the subject, the investigator, or the study site staff. All deviations occurring in a DMID-funded trial must be reported to DMID. For more specific documentation instructions, please see the
Protocol Deviation Reporting and Form Completion Guidelines
It is the responsibility of the site PI/study staff to use continuous vigilance to identify and report deviations within 5 working days of identification of the protocol deviation, or within 5 working days of the scheduled protocol-required activity. If the Emmes Corporation is responsible for the applicable clinical study data management, protocol deviation report forms are filled out and submitted via the Emmes internet data entry system (IDES - known also as Advantage EDC™) in this instance, no additional submission is required.
For studies that are not supported by Emmes, Protocol Deviation reports must be submitted in one of three ways:
No matter which way you choose, the form must be printed, and then signed and dated for your files.
If you realize that an error was made once the fax-based form is submitted, please correct the original deviation form, and fax to CROMS, noting on the cover page what has changed.
When submitting via the web-based form, a reference number associated with the submission will be generated. If you realize that an error was made once the web-based form has been submitted, use any of the Report a
Protocol Deviation Submission Error links to notify CROMS.
If an error was made on a protocol deviation submitted via e-mail, please e-mail a completed e-mail/fax transmittal form, and in the comments section, note what information has changed.
If you have any questions, please contact us via email at
firstname.lastname@example.org and a Protocol Deviation Team member will assist you.