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BeaconCR · Free Resource

Physician Registry Launch Checklist

35 concrete steps across 7 phases to take a clinical observation from an idea to a registered, IRB-ready observational registry.

This checklist is for guidance only and is not legal, regulatory, or medical advice. IRB exemption or approval is the decision of the reviewing IRB. ClinicalTrials.gov registration acceptance is the decision of ClinicalTrials.gov reviewers.

Phase 1 — Concept

Define what you are tracking, in whom, and why. The concept work prevents wasted protocol effort later.

  1. Write one sentence describing the population, intervention or exposure, and what you want to observe.
  2. Decide whether this is observational (registry) or interventional (trial). Most physician-driven projects start as observational registries.
  3. List the primary outcome you most want to capture (e.g., pain reduction, functional score, biomarker change, safety event).
  4. List 2-3 secondary outcomes that you can realistically measure at follow-up visits.
  5. Identify any sponsor, partner, or external interest. Decide who the responsible party will be if the registry is later registered.

Phase 2 — Protocol Draft

Translate the concept into registry-shaped language. This becomes the spine of every downstream document.

  1. Draft inclusion and exclusion criteria. Keep them clinically realistic and capture-able from your existing intake process.
  2. Define the enrollment target and the time window. Be honest about referral volume — small registries that finish beat large registries that stall.
  3. Define the follow-up schedule (e.g., baseline, 3 months, 6 months, 12 months). Specify what is captured at each visit.
  4. Define validated patient-reported outcome (PRO) instruments if applicable (e.g., KOOS for knee, ODI for low back, FIM for function).
  5. Define safety observations: what you will record, how you will record it, and when it triggers a report.

Phase 3 — IRB Readiness

Assemble the package an IRB needs to make a determination.

  1. Decide whether you will use a local IRB, an institutional IRB, or an external commercial IRB. For solo / small-group physicians, an external commercial IRB is usually fastest.
  2. Prepare the protocol document with: background, objectives, design, eligibility, procedures, statistical considerations, data handling, and references.
  3. Draft the informed consent form (ICF) including purpose, procedures, risks, benefits, alternatives, voluntary participation, withdrawal rights, data handling, and contact information.
  4. Draft the HIPAA authorization (separate or combined with ICF per your IRB's convention).
  5. Prepare recruitment materials (patient-facing flyers, web copy, intake form) for IRB review. Recruitment language is reviewed for compliance with IRB-approved wording.

Phase 4 — Patient Intake

Build the consent, intake, and enrollment workflow that the registry will actually run on.

  1. Decide whether intake is public-facing (a form on your website) or physician-referral (you invite patients from inside the clinic). Either pattern uses the same consent + HIPAA + baseline workflow.
  2. Build the baseline questionnaire: demographics, eligibility confirmation, baseline PROs, baseline labs or measurements.
  3. Establish a consent capture mechanism (in-person or e-consent). Track consent versioning so every patient is linked to the exact ICF version they signed.
  4. Establish a patient identifier scheme that lets you de-identify exports later without losing the ability to look up the patient internally for safety follow-up.
  5. Decide how follow-up reminders are sent (SMS, email, phone) and who is responsible for re-contact when a patient misses a window.

Phase 5 — Data Capture

Configure outcomes, cadence, and follow-up so that every patient generates the data the protocol promised.

  1. Build the data dictionary: every field, its type, its allowed values, and what is required vs. optional.
  2. Configure each follow-up visit form to match the protocol cadence. Be ruthless about cutting fields you will not analyze.
  3. Set up missing-data tracking. The first export will look honest because you tracked what you did not collect, not just what you did.
  4. Plan for data quality review (e.g., a periodic check that PRO scores fall in valid ranges, that dates are consistent, that consent dates precede first visit dates).
  5. Decide on storage discipline: encryption at rest, audit logging, access controls, retention period, breach response plan. (BeaconCR provides all of this; if self-hosting, it is your responsibility.)

Phase 6 — PRS Submission

Prepare the ClinicalTrials.gov Protocol Registration and Results System (PRS) record when the study is eligible.

  1. Run a PRS eligibility check against FDAAA 801, NIH policy, and ICMJE. Not every observational study qualifies. Skip this phase cleanly if yours does not.
  2. Determine the responsible party (sponsor or sponsor-investigator). Every PRS submission needs one.
  3. Draft the PRS record fields: study identification, conditions, interventions, eligibility, outcome measures (in PRS-style language), study design, locations, contacts.
  4. Format outcome measures per PRS conventions. Reviewers see fewer revision requests when the language is precise from the start.
  5. Submit to the responsible party for sign-off, then submit through ClinicalTrials.gov. Be honest with your patients and partners: NCT assignment is up to ClinicalTrials.gov reviewers, not the submitter.

Phase 7 — Ongoing Management

Run the registry and report on it. The work after launch is what turns a registry into evidence.

  1. Establish an enrollment monitoring cadence. A weekly check on new enrollments, follow-up completion, and protocol deviations catches drift early.
  2. Prepare annual PRS updates for registered studies. Outdated registry records are a compliance liability.
  3. Generate periodic reports for the responsible party, sponsor (if applicable), and your own quality-improvement use.
  4. Prepare exports for biostatistics or publication when the data warrants it. Every export ships with a data dictionary so receiving analysts understand each field.
  5. Be ready to close the registry honestly: final report, final PRS update, and an archival snapshot. A clean close is part of credibility.

Skip the manual checklist: BeaconCR runs all 35 steps inside a physician study workspace. Start free at beaconcr.com/physician-study-intake.

© BeaconCR · Healing Hope International. Observational registry data is hypothesis-generating and is not equivalent to RCT data.