Clinical research checklists keep the paperwork around a study from stalling it: the documents an IRB expects, what a monitor confirms before a site opens, the order of a ClinicalTrials.gov results record. The Study checklist module in the Proposal Studio has five of them. Each is a blank template you can copy for free, or you describe your study and get a version tailored to it: a table with each item, what your study needs, whether it applies, an owner and a Done box. It is for study coordinators, investigators, research nurses, and students running their first study with human participants.
What it does
| Checklist | What the base list covers |
|---|---|
| IRB or ethics committee submission | Application form, versioned protocol, investigator CVs and training, recruitment materials, consent and assent documents or a waiver request, instruments, risks and safety monitoring, privacy, vulnerable participants, payment, conflicts of interest, other approvals, funding, version control |
| Site initiation visit (clinical trial) | Approvals and agreements, the investigator site file, delegation log, protocol training, consent process, investigational product, safety reporting, data collection, monitoring, samples and laboratory, equipment, recruitment, close of the visit |
| ClinicalTrials.gov results submission | The PRS results sections in order: participant flow, baseline characteristics, outcome measures, statistical analyses, adverse events, limitations, certain agreements, point of contact, documents, review |
| Translating consent forms | Source version, translator, forward translation, back translation or independent review, reconciliation, local and cultural review, attestation, ethics approval, version control, short form process, interpreters and witnesses |
| Incidental findings plan | What may be found, what will and will not be returned, who reviews the data, consent, confirmation in a clinical laboratory, communication, referral and costs, urgent findings, records, special situations, ethics review |
The ClinicalTrials.gov checklist starts with "Before you start": the protocol section must be current, and results for applicable clinical trials are usually due within one year of the primary completion date . Outcome measures must match the registered outcomes exactly, and the tailored version keeps that rule.
What a tailored checklist adds
A tailored checklist returns three parts:
- Checklist: a table with the columns #, Item, What this study needs, Applies (yes, no or check), Owner, and Done. Every Done cell starts as "[ ]", and "[owner]" marks an owner still to be named.
- Easy to miss for this study: three to five points specific to your design, sites or population.
- Open questions: what you still have to find out or decide.
Every base item is kept. Items that do not apply are marked "no" with the reason, so a reviewer can see they were considered. Items the study clearly needs are added and marked "(added)".
Blank or tailored?
Use the blank checklist when your institution already has its own process and you only want a reminder list to compare against, or when the study is small and you will fill it in yourself in a few minutes. Use the tailored version when the study has features that change the list: several sites, a device or drug, participants who speak other languages, genomic data, or a sponsor with its own requirements. The tailored checklist is also easier to hand to a team, because each row has an owner and a Done box from the start.
How it works, step by step
- Open the Proposal Studio and choose Study checklist under Checklists (the route is /proposals?module=study-checklist).
- Pick the checklist: IRB or ethics committee submission, site initiation visit, ClinicalTrials.gov results submission, translating consent forms, or incidental findings plan.
- Under Your study, describe the design, population, sites, what you collect, the intervention or product, the languages and the committee or registry involved. You can paste text or upload your protocol summary.
- Optionally add deadlines, what is already done and your institution's own requirements.
- Press Run. The tailored table streams in.
- Press Open in editor to assign owners, tick items and export the checklist to Word or PDF for the team.
For a blank copy, open the editor's templates and choose the checklist by name, for example "Checklist: site initiation visit". It costs nothing.
A worked example
Example (invented for illustration): a research coordinator is opening a second site for a two-arm trial of a wound dressing at a community hospital. Some participants speak Spanish.
- She chooses Site initiation visit, pastes a summary of the protocol and notes that the new site has no on-site pharmacy. Cost: 3 credits.
- The table marks the investigational product rows for storage and accountability as "check", adds an item for transferring dressings from the lead site "(added)", and lists the temperature log as easy to miss.
- She runs Translating consent forms for the Spanish consent: 3 credits. The table keeps the back translation and attestation rows and leaves the committee's own translation requirement as "[check with your committee, registry or sponsor]".
- For the IRB amendment she copies the blank IRB or ethics committee submission checklist: 0 credits.
Total: 6 credits, inside the Free plan's 45 a month.
What it does not do
- It is not regulatory or legal advice. The sponsor, your IRB or ethics committee and your institution's SOPs decide what is required, and their version wins wherever it differs.
- It does not invent regulations, deadlines, form numbers or committee names. Where it cannot know a local rule, it says so.
- It does not submit anything. It does not log in to the PRS, your IRB system or an eTMF.
- It does not replace a monitor's visit or a sponsor's own site initiation checklist; use it to prepare for those.
- The incidental findings plan is a planning aid. Decisions about returning results need clinical and genetic expertise and committee approval.
Who uses it
- Clinical research coordinators, research nurses and investigators: see AI for medicine and medicine and health research.
- PhD students running a study with human participants: see AI for PhD students.
- Academics setting up a multi-site study: see AI for academics.
When the manuscript is written, write the approval statement with the ethics approval statement template, and check the paper against CONSORT, STROBE or another guideline with the reporting guideline checker. To draft the proposal itself, use the Proposal Studio.
Learn more
- Site initiation visit checklist: what to confirm before a site opens
- ClinicalTrials.gov results reporting, section by section
- How to write an IRB application
Last updated 2026-11-13