BEACONCR — CLINICAL RESEARCH REGISTRY & REGULATORY COORDINATION

Physician / Site Enrollment for IRB Reviewed Registry and Expanded Access Support

BeaconCR coordinates physician/site prequalification, regulatory documentation, independent IRB review or concurrence, observational registry participation, and patient specific Expanded Access support for eligible physician led investigational pathways involving Kurve Therapeutics intranasal delivery technology.

Submission of this form does not authorize treatment, activate a site, enroll a patient, confirm sponsor participation, or constitute FDA authorization, IRB approval, IRB concurrence, product approval, or device access. BeaconCR will review the submitted information and coordinate next steps only after applicable regulatory, sponsor, IRB, informed consent, and documentation requirements are evaluated.

Choose Your Enrollment Pathway

BeaconCR separates general physician/site prequalification from patient specific Expanded Access support. A physician or site may begin with prequalification before identifying a specific patient. Form FDA 3926 support, however, is patient specific and requires additional patient, product, sponsor, IRB, and FDA documentation before treatment may begin.

This intake form allows BeaconCR to evaluate physician/site eligibility, registry fit, and potential Expanded Access documentation needs. Submission does not authorize treatment, activate a site, enroll a patient, confirm sponsor participation, or constitute FDA or IRB approval. BeaconCR will coordinate next steps only after applicable regulatory, sponsor, IRB, and informed consent requirements are reviewed.

1. Physician & practice information

Required for all intake types. These fields establish physician identity and practice location and may be used in regulatory documentation if a patient specific submission is later prepared.

1b. Physician qualification statement

Optional supporting information. If patient specific Expanded Access documentation is later prepared, FDA generally expects either a structured qualification statement or the first few pages of the physician's CV.

Max 10 MB. Will be retained securely and may be attached to a future patient specific submission if one is prepared.

2. Physician participation interest

Select all that apply. At least one is required.

Physicians who provide treatment, enroll patients, receive referrals, or financially participate in a registry or treatment pathway may have conflicts of interest that prevent them from serving as independent IRB reviewers for the same protocol. BeaconCR coordinates independent IRB review or concurrence through appropriate external pathways.

3. Do you have a specific patient for Expanded Access review?
8. IRB review / concurrence pathway

BeaconCR may coordinate submission of applicable materials to an independent IRB, IRB chair, or IRB designee review pathway, as appropriate. Site activation, registry participation, or patient specific Expanded Access treatment may not begin until written IRB approval, concurrence, acknowledgment, or other applicable documentation has been issued for the relevant protocol, informed consent materials, registry documents, or patient specific Expanded Access package.

Physicians who are treating patients, enrolling patients, receiving referrals, or otherwise participating financially or clinically in a registry or investigational pathway may not be eligible to serve as independent IRB reviewers for the same protocol.

9. Sponsor Letter of Authorization / cross reference

If applicable and authorized by the relevant sponsor, BeaconCR may include a Letter of Authorization permitting FDA to cross reference the applicable IND, IDE, device file, or other regulatory submission. If no applicable LOA is available, BeaconCR will coordinate with the physician and sponsor to determine whether sufficient product, quality, safety, manufacturing, device, and regulatory information is available to support a submission.

10. Optional observational registry participation

If a patient's clinical care or Expanded Access treatment proceeds independently and the patient meets eligibility criteria, the patient may be offered participation in one or more IRB reviewed observational registries for real world data collection. Registry participation does not authorize treatment, assign treatment, replace Form FDA 3926 requirements, replace informed consent, or substitute for physician judgment.

Optional: indicate alignment with a specific Kurve study code (if known)
11. FDA authorization timing

For non emergency individual patient Expanded Access, treatment may not begin until FDA allows the request to proceed or the applicable waiting period has passed, and IRB approval or authorized IRB chair/designee concurrence has been obtained. BeaconCR may assist with documentation, but the treating physician remains responsible for ensuring that treatment does not begin before applicable FDA, IRB, sponsor, informed consent, and institutional requirements are complete.

12. Emergency use pathway (optional)

If treatment is requested under an emergency Expanded Access pathway, the treating physician must follow FDA emergency expanded access procedures, including communication with the appropriate FDA review division and timely follow up documentation. BeaconCR may assist with documentation, but emergency authorization, physician responsibility, IRB notification, informed consent requirements, and follow up submissions remain subject to FDA, IRB, and institutional requirements.

13. Privacy & minimum-necessary use

BeaconCR will collect only the minimum necessary patient and physician information required for intake review, regulatory coordination, registry assessment, and documentation support. Identifiable patient information should be submitted only through designated secure patient enrollment or regulatory document channels. BeaconCR will use submitted information only for the applicable regulatory, IRB, registry, sponsor coordination, and clinical research workflow.

14. Electronic signature & attestation
Electronic signature block

Your submission timestamp and IP address will be recorded as part of the audit trail under the ESIGN Act.

BeaconCR Physician Enrollment Workflow

How a physician intake moves through BeaconCR coordination.

  1. 1
    Physician submits intake form

    BeaconCR receives physician credentials, practice details, patient population, and treatment or registry interest.

  2. 2
    BeaconCR reviews pathway fit

    BeaconCR determines whether the request is best categorized as registry participation, referral participation, physician led Expanded Access support, Form FDA 3926 preparation, site prequalification, or advisory interest.

  3. 3
    Sponsor and product documentation review

    BeaconCR confirms whether sponsor authorization, LOA, IND/IDE cross reference, product quality data, manufacturing records, Certificate of Analysis, sterility documentation, dose rationale, safety data, and device documentation are available.

  4. 4
    IRB review / concurrence coordination

    BeaconCR coordinates submission to the appropriate independent IRB, IRB chair, or designee pathway for the relevant protocol, consent documents, registry materials, or patient specific Expanded Access package.

  5. 5
    FDA pathway support if applicable

    For individual patient Expanded Access, BeaconCR may assist the licensed physician with Form FDA 3926, supporting rationale, treatment plan, sponsor LOA if available, and follow up submission requirements.

  6. 6
    Written activation confirmation

    BeaconCR confirms when applicable FDA, IRB, sponsor, informed consent, and documentation requirements have been completed.

  7. 7
    Physician led care and consent

    The treating physician remains responsible for patient care, clinical decision making, informed consent, safety monitoring, adverse event reporting, investigational product accountability where applicable, and follow up reporting.

  8. 8
    Real world data collection

    If the patient consents and qualifies for an observational registry, BeaconCR supports outcomes tracking and data collection under the IRB reviewed registry protocol.

Regulatory and Research Disclaimer

BeaconCR is a clinical research registry and regulatory coordination platform. BeaconCR does not diagnose, treat, prescribe, manufacture, sell, ship, administer, or guarantee access to any drug, biologic, cell therapy, extracellular vesicle product, exosome product, device, or investigational treatment. Submission of this form does not constitute FDA authorization, IRB approval, IRB concurrence, sponsor authorization, product approval, treatment approval, site activation, or patient enrollment. Any physician led treatment, individual patient Expanded Access request, Form FDA 3926 submission, sponsor Letter of Authorization, IRB review, informed consent process, or observational registry participation must be completed in accordance with applicable FDA regulations, IRB requirements, institutional policies, sponsor requirements, and physician clinical judgment.

BeaconCR coordinates physician/site onboarding, IRB reviewed observational registry participation, and patient specific Expanded Access documentation support for eligible physician led investigational pathways.