1. Decide what kind of research fits your practice

Start with your patients. Sponsors look for sites with access to the people a study needs, so list the conditions you treat, how many eligible patients you see, and the study types your office could realistically support.

2. Name your investigator and research lead

A study needs a principal investigator who takes responsibility for its conduct, and someone to run the daily work, usually a clinical research coordinator. Be honest about their time. Research visits, documents and monitor visits add up, and practices often underestimate the workload.

3. Complete the required training

Sponsors commonly expect Good Clinical Practice (GCP) training for the study team, plus protocol-specific training for each study. Keep certificates, licenses and CVs organized from the start, because you'll be asked for them.

4. Prepare your space and equipment

Depending on the study, you may need:

  • Private space for consent discussions and study visits
  • Secure storage for records and limited-access storage for investigational product
  • Calibrated equipment and temperature monitoring for refrigerators and freezers
  • A way to process, store and ship lab samples

5. Find your first study

Studies usually come through sponsors, contract research organizations (CROs) and site networks. Build relationships with people already doing this work, because their introductions can open doors. Expect to sign a confidentiality agreement, complete a feasibility questionnaire and possibly host a qualification visit.

6. Negotiate the contract and budget

Read the budget against the protocol, line by line. Count the staff time for each visit, and ask about start-up fees, screen failures, unscheduled visits, close-out and record storage. Have a lawyer review the clinical trial agreement.

7. Get approvals and start up

Before enrolling, the study needs institutional review board (IRB) approval, and drug studies under an IND typically need a signed Form FDA 1572. You'll also build your regulatory binder and delegation log, then complete a site initiation visit with the sponsor or CRO.

8. Set up your records before the first subject

Decide how you'll track consent, source data, visit windows and invoices before the first visit. It's much easier than rebuilding your process mid-study. PAS OneCore is built for this kind of practice.

This guide is general information, not legal or regulatory advice. Requirements vary by study, sponsor and location, so confirm them with your sponsor, IRB and legal counsel.