Document bundles
Study conduct document bundle
A coordinated set of 16 conduct working templates with completion guidance. Each document needs study-specific adaptation and review.
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Study conduct document bundle
A coordinated set of 16 conduct working templates with completion guidance. Each document needs study-specific adaptation and review.
Included documents are listed below. Purchase and licence terms remain subject to operator confirmation.
Included templates
- Screening and enrolment log
- Consent process tracking log
- Participant visit tracking log
- Case report form design worksheet
- Protocol deviation log
- Adverse event assessment worksheet
- Serious adverse event reporting tracker
- Investigational product accountability log
- Medical device accountability log
- Temperature excursion record
- Sample shipment and reconciliation log
- Monitoring visit report
- Action item and query tracker
- Corrective and preventive action plan
- Amendment and version control log
- Annual progress report worksheet