Global Health Trials Tools and Templates library

The Global Health Trials platform, part of the Tropical Health and Education Trust (THET) Global Health Network (TGHN), maintains this library with the aim to strengthen equity in access to research knowledge - with practical, ready-to-use tools and templates.

Documents are listed by category on a single page; each template is individually downloadable.

Tools and templates are organised in the following categories:

• General logs and trackers (telephone logs, meeting minutes, budget templates)
• Developing protocol (concept protocol, feasibility checklist, risk assessment)
• Finances management (budget monitoring tools, cost-by-category and cost-by-patient tools)
• Essential documents (checklists, trial master file contents list)
• Enrolling and retaining participants (enrolment log, screening logs, visit logs, withdrawal log, retention plan)
• Informed consent and counselling (multiple consent templates by study type: generic, clinical trial, observational, interview, sampling; consent monitoring checklist)
• IMP management (drug accountability, pharmacy forms, receipt and destruction records, temperature log)
• Data management (data management plan, CRF templates, DSMB charter, data clarification forms)
• Study and site management (site selection, initiation, readiness, close-out checklists, delegation of authority log)
• Staff management (training log, study team responsibilities)
• Ethics and human subjects protection (ethics committee application and approval letters, risk assessment)
• Risk, safety, and adverse events (AE/SAE record, log, reporting checklist, SAE form)
• Agreements, approvals, and contracts (clinical trial agreement, NDA template, interviewer contracts)
• Quality assurance (monitoring plan, visit log, checklists, monitoring curriculum to enable equity in access to research knowledge
• Protocol adherence (deviation and violation logs)