OPTIMA non-compliance reporting

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OPTIMA Non-compliance report

Please complete the below information to inform WCTU of a Protocol Non-compliance.

It is the ICC responsibility to ensure appropriate Corrective and Preventative actions (CAPA) are put in place. The ICC team should also work with the Site to find the Root Cause for the Non-compliance, to reduce the risk of incidents happening again.

WCTU can provide a CAPA report template for use if required.

Name of person making request

International Coordinating Country

Date ICC became aware of incident

Date of incident (please leave blank if not known)

Participant TNO

Please double check the TNO is correct before submitting to WCTU. If this is not relating to a specific TNO / relates to more than one participant, please enter 0 in this box.

Event details

Assessment outcome

Event Category

Event Impact Assessment

Yes

Potential

Patient Safety impact

Trial Integrity impact

Privacy notice

The information you provide will be shared with the OPTIMA Sponsor and Trial Management Group but will not be shared more widely. The above information will be sent to OPTIMA@warwick.ac.uk to allow us to document the non-compliance.

The University of Warwick is the Data Controller of any information you have entered on this form and is committed to protecting the rights of individuals in line with Data Protection Legislation. The University's Data Protection webpages provide further information on your rights and how the University processes personal data. If you wish to submit a data subjects rights request, make a complaint or report a suspected personal data breach, please contact the University’s Data Protection Officer by email at infocompliance@warwick.ac.uk.

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OPTIMA non-compliance reporting

OPTIMA Non-compliance report

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