Document bundles
Study start-up document bundle
A coordinated set of 11 startup working templates with completion guidance. Each document needs study-specific adaptation and review.
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Study start-up document bundle
A coordinated set of 11 startup 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
- Ethics submission package checklist
- Regulatory submission tracker
- Participant information sheet outline
- Informed consent form outline
- Recruitment materials review checklist
- Site qualification visit report
- Site initiation visit report
- Delegation of duties log
- Study training log
- Essential document index
- Site contact and escalation list