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If you have a study that meets the either the FDA or NIH definition of a clinical trial:

1. Request an account - email [Research Compliance Officer]

2. Include your name, current email address and telephone number. You may also request accounts for other individuals on your study team who will need access to view or edit the ClinicalTrials.gov record.

3. When your account is created you will receive two emails:

   1. From the Protocol Registration System (PRS), the ClinicalTrials.gov online system, with your username, temporary password and a link to the PRS log in page

   2. From [Research Compliance Officer], with step-by-step instructions for getting a record started

4. Any study records you have started or records on which you have been added will be available to you for needed revisions, updates or addition of new information.

ClinicalTrials.gov site: https://clinicaltrials.gov/ct2/about-site/background

FDA Information: https://clinicaltrials.gov/ct2/manage-recs/fdaaa

NIH Information: https://grants.nih.gov/policy/clinical-trials/definition.htm

ICMJE Recommendations: http://www.icmje.org/about-icmje/faqs/clinical-trials-registration/

https://www.hopkinsmedicine.org/research/resources/offices-policies/OPC/Outside_Interests/COI_COC/

• FDA https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

• CITI https://about.citiprogram.org/

Miye Schakne, Research Compliance Officer mschakne@jhu.edu

Conflict of Interest and Commitment (COIC) and Disclosure