Study start-up is the work between a site being considered for a trial and being ready to enroll. The order and details vary by sponsor and study, so treat this as a starting point and adjust it to your protocol and contract.

Feasibility

  • Sign the confidentiality agreement and review the protocol synopsis
  • Check your patient population against the entry criteria
  • Confirm staff time, space, equipment and storage
  • Complete the feasibility questionnaire
  • Prepare for the qualification visit, if there is one

Contract and budget

  • Review the clinical trial agreement
  • Price each visit and procedure, including your staff time
  • List invoiceable items, such as screen failures and start-up fees
  • Complete a coverage analysis if your study needs one

If this is your first budget, our guide on clinical trial budget vs actuals shows how it gets used during a study.

Regulatory and IRB

  • Collect essential documents, such as CVs, licenses and financial disclosures
  • Submit to the IRB and file the approvals
  • Set up the regulatory binder
  • Complete the delegation log and required training

Operations

  • Build the schedule of activities and visit windows
  • Prepare source templates and the current consent form
  • Set up lab kits, sample handling and equipment calibration
  • Arrange investigational product storage and temperature logs, if needed

Activation

  • Complete the site initiation visit
  • Confirm the sponsor's activation or green light
  • Start recruiting under your approved plan

Keeping it all in one list

Start-up work often runs in parallel across inboxes, spreadsheets and paper. Our clinical trial study start-up software keeps feasibility, a start-up checklist and readiness tracking with the study, so what you set up is in place when the first subject arrives.

Starting a new study soon?

Tell us where your site is in the process, and we'll show you how PAS OneCore could help.

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