When the investigator is also the sponsor, nobody else is holding the regulatory, safety and data tasks. This checklist orders them by dependency so a small academic team can see what blocks what, and what can run in parallel.
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Done
9 of 22
Blocking
3
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Why IITs are different
A company-sponsored trial arrives with a clinical operations team, a regulatory affairs function, a pharmacovigilance group and a data management vendor. An investigator-initiated trial has the principal investigator, a coordinator or two, perhaps a research nurse and a statistician who is also helping three other projects. The tasks do not disappear. They fall to the same few people, which is why the order matters.
In practice, the sponsor-investigator’s duties include the decisions a sponsor would make: the regulatory route, the monitoring approach, safety reporting to regulators and ethics bodies, drug or device accountability, and records retention, as well as the investigator duties at the site. See software for investigator-initiated trials for the tooling view; this page is the task list.
The checklist
Treat the right-hand column as the dependency. Anything with no dependency can start on day one.
| Phase | Task | Depends on / note |
|---|---|---|
| 1. Foundation | Protocol with objectives, endpoints, eligibility, visit schedule and analysis outline | Everything else. See protocol template |
| 1. Foundation | Funding, budget and who pays for what | Needed for contracts. See budget template |
| 1. Foundation | Statistical plan and sample size | Protocol endpoints |
| 2. Regulatory | Decide the pathway: IND, exemption or equivalent, and write the rationale | Product and indication. Check the exemption criteria with your regulatory office. See FDA IND guide for academics |
| 2. Regulatory | Prepare and submit regulatory application where required | Chemistry, nonclinical and clinical sections; wait for the response period |
| 2. Regulatory | Investigator statement and financial disclosure forms where applicable | Regulatory pathway |
| 3. Ethics | IRB or ethics committee submission with consent form and recruitment materials | Protocol, consent. See IRB submission checklist |
| 3. Ethics | Data protection assessment where required | Data flow from the data management plan. See DPIA template |
| 4. Registration | Public trial registration drafted and submitted before first enrolment, where required | Protocol. See ClinicalTrials.gov guide |
| 5. Safety | Safety reporting plan: who classifies, who reports, to whom, in what time | Protocol, regulatory pathway. See SAE deadline calculator |
| 5. Safety | Data monitoring approach, including whether an independent monitor or committee is needed | Risk assessment. See risk management plan template |
| 6. Data | Data management plan, eCRF design, edit checks and roles | Protocol final. See data management plan template |
| 6. Data | User acceptance testing with realistic dummy data | Forms built. See UAT sandbox |
| 6. Data | Consent and ePRO workflow tested end to end, including export | Ethics-approved wording |
| 7. Site | Delegation log, training records, CVs and licences | Team agreed. See delegation log template |
| 7. Site | Investigator site file set up | See site file index template |
| 7. Site | Product supply, accountability and storage procedures where relevant | Regulatory pathway |
| 8. Activation | Final go-live review: approvals, registration, training, safety contacts, tested data capture | All of the above |
Phases overlap. Ethics, registration drafting and data build can all run while the regulatory pathway is being decided.
Where IITs lose time
Most delays are not exotic. They are the same few tasks done late.
Ask your regulatory office early whether the study needs an IND or an exemption, because the answer changes the protocol’s safety language, the monitoring plan and the timeline. Write down the reasoning and keep it in the study file.
For trials that fall under the registration rules, the deadline is tied to the first enrolment, and journals expect prospective registration. Put it on the checklist as a pre-enrolment gate. Check the current rules for your trial type.
Reporting deadlines for serious unexpected events are short. Decide who receives the report from the site, who assesses it, who files and where the contact numbers are kept. Write it down before the first dose.
Data capture built under time pressure produces vague fields and no edit checks. Build forms from the final protocol, test them with dummy participants in a sandbox, and fix the schedule of assessments first. See schedule of assessments builder.
A delegation log completed after procedures were performed is an inspection finding waiting to happen. Fill it in before anyone consents a participant, and update it when staff change.
Export a few dummy participants during UAT and open the file in your analysis software. A mismatch found at database lock costs far more than one found in week two of start-up.
Data capture, built in the sandbox first
Capture’s free sandbox contains every feature. A small team can draft visits and forms (including from an uploaded protocol, with human review before anything is saved), add edit checks, test skip logic, e-signatures and the audit trail with sample data, and go live only when the checklist is green.
Pre-launch readiness
1 site activated
1 form not yet approved
Upload your protocol to the free sandbox, review the draft visits and forms, and run a dummy participant through the whole study.
Gate
Regulatory (where required) and ethics, with the approved consent version on file.
Where required, with the identifier in the study file.
Named people, contact numbers, forms and timelines.
Every person who will touch participants or data is on it.
Protocol, GCP, data capture and safety reporting.
Forms tested with dummy data; edit checks verified.
Least-privilege access, with coordinators and the PI set up.
A dummy dataset opened in the analysis tool.
If a product is involved, accountability forms and storage are in place.
Who reviews what, and how often.
In US drug regulations, 21 CFR 312.3 describes it, broadly, as an individual who both initiates and conducts an investigation and under whose immediate direction the product is administered. That person has both sponsor and investigator duties. Check the current text and the rules where you work.
No. Some studies of marketed products can qualify for an exemption, depending on criteria set in the regulations. The decision is specific to the product, population and design, so ask your institution’s regulatory office and document the rationale. See the FDA IND guide for academics.
The long-lead items: the protocol, the regulatory pathway decision, the ethics submission, the funding and contracts and the safety reporting plan. Data capture build can run in parallel once the protocol is stable.
Usually the sponsor-investigator, which is why a safety plan with named people and timelines belongs on the start-up checklist. Reporting duties to regulators and ethics bodies depend on the jurisdiction and pathway.
Yes, if the build is simple and tested. Capture is self-serve, with AI drafting of visits and forms from a protocol (always reviewed by a human), edit checks that raise queries automatically and a free sandbox to test everything first.
No. Capture is the data capture platform: EDC, eCRF, ePRO and eConsent with an audit trail. Regulatory applications, ethics submissions and registration are done by the study team. Capture can export a blank eCRF PDF to support an ethics submission.
No. It is a planning aid. Regulatory requirements vary by country, product and trial design, so confirm each item with your regulatory office, ethics committee and, where needed, counsel.
Keep exploring
Software for investigator-initiated trials
Tooling for IIT teams.
FDA IND application guide for academics
IND or exemption.
IRB submission checklist
What to send the ethics committee.
ClinicalTrials.gov registration guide
Registration before enrolment.
Delegation log template
Who is allowed to do what.
Investigator site file index
Organise the site file.
Data management plan template
Plan data capture and review.
Good clinical practice (GCP)
The quality standard.
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