Clinical Trial Site Initiation Checklist Template

Answer the two scope questions first. They decide whether the FDA phase and the pharmacy phase appear.

• Name the PI, study coordinator and pharmacy lead — later tasks are assigned from these three fields
• Answer the scope questions — is the study FDA-regulated under an IND or IDE, and will the site store or dispense investigational product
• Sign the confidentiality agreement — through your research office, before the sponsor sends the protocol
• Complete the feasibility questionnaire — enrolment estimates based on your real patient population and competing studies
• Host the site qualification visit — the sponsor or CRO checks staff, facilities, equipment and record keeping
• Record the selection decision and contacts — the selection letter, the monitor and start-up contacts, and target activation date

• Confirm the reviewing ethics committee or IRB — local or single IRB with a reliance agreement, or the UK combined review
• File the approval and approved consent documents — the approval letter and the current approved versions, so only those are used
• Build the budget from the schedule of assessments — per-visit costs, start-up and pharmacy fees, screen failures and closeout
• Negotiate the clinical trial agreement — payment terms, indemnity, participant injury, publication and data clauses, through your contracts office
• Complete institutional and ancillary reviews — radiation, biosafety or scientific review; NHS capacity and capability confirmation in England and Wales
• File the fully executed contract — signed by every party, with the final budget attached

Shown only when the study is FDA-regulated under an IND or IDE.

• Complete Form FDA 1572 or the investigator agreement — the 1572 for drugs and biologics, or the signed agreement for devices
• List sub-investigators, labs and facilities accurately — everyone and everywhere named must match the delegation log and contract
• Collect each investigator’s financial disclosure — on the sponsor’s form, updated during the study and for one year after
• Brief investigators on their FDA obligations — supervision, drug or device control, records, reporting and IRB review of changes

The PI sign-off of the delegation log halts the checklist. Nobody starts trial activities until it is given.

• Open the investigator site file — paper or electronic, using the sponsor’s index of essential records
• File CVs, licences and GCP certificates — current copies for the PI and every person who will take on trial activities
• Complete protocol-specific training — for each team member, recorded before they take on any delegated activity
• Build the delegation log — each person, the activities delegated to them and a start date
• File lab certifications and normal ranges — for every local lab the protocol uses, as the sponsor requests
• PI sign-off of the delegation log — the PI confirms each person is qualified and trained for what is delegated

Shown only when the site stores or dispenses investigational product.

• Agree the storage location and access — secure, restricted to delegated staff, and separate from routine stock
• Set up temperature monitoring and excursion handling — calibrated monitoring, out-of-hours alerts and the sponsor’s excursion process
• Prepare accountability and dispensing records — receipt, dispensing, returns and destruction, on the sponsor’s logs or your own
• Train pharmacy staff on the pharmacy manual — preparation, labelling, blinding and dispensing steps, recorded on the delegation log
• Receive and acknowledge the first shipment — check condition and temperature data, then acknowledge it in the sponsor’s system

• Request EDC, IRT and sponsor portal accounts — for each delegated person, after their system training is complete
• Check equipment and calibration records — freezers, centrifuges, ECG machines and scales the protocol depends on
• Set up lab kits and sample shipping — central lab kits, courier accounts and shipping training for anyone packing samples
• Schedule the SIV with the whole team — the PI attends, with pharmacy, lab and any other delegated staff
• Hold the site initiation visit — protocol, consent, eligibility, safety reporting, product handling and data entry
• Close the SIV follow-up actions — each item from the monitor’s report answered and filed

• Record the sponsor’s green light — attach the activation letter or email with its date
• Confirm the recruitment and screening plan — approved materials only, with a screening log ready
• Notify supporting departments — pharmacy, labs, imaging and clinics know the study is open
• Rehearse the first participant visit — walk visit one end to end, including consent and source documents
• Review the first visit within days — consent, eligibility and data entry checked against source