ClinicalTrials.gov This website provides information to help investigators and research coordinators at Albert Einstein College of Medicine and Montefiore Medical Center understand the requirements and responsibilities for registering clinical trials and reporting results on ClinicalTrials.gov. ClinicalTrials.gov is a public registry established by federal mandate as a means to provide public access to information on clinical trials for a wide range of diseases and conditions. Registration and, for certain studies, results reporting are required by regulatory and funding agencies including FDA, NIH, ICMJE, and CMS. The Protocol Registration and Results System (PRS) is used to register clinical studies and to submit results information for registered studies. You must have a PRS account to register study information on ClinicalTrials.gov. If you are assisting a PI, they will need their own account as well, if they do not already have one set up. How Do I Set Up My Account? To set up a user account and password: Send an email requesting an account to clinicaltrials.gov@einsteinmed.org In the subject line enter: “CT.gov Account Request” In the body of the email provide the following information Requestor’s Name: Organization (is payroll from Einstein or Montefiore?): Email: Phone Number: Department: Title: IRB# (of trial being registered): If you need acces to all of your PI’s trials in the PRS please list their name(s) here: You will receive an email within 48 hours of your request with your login name and temporary password Log into the PRS system using your login name and temporary password Navigate to the ‘Accounts’ tab and select “Change Password” to replace your temporary password with something you can remember Which Trials Should Be Registered on ClinicalTrials.gov? In general, the following clinical trials must be registered on ClinicalTrials.gov: Applicable Clinical Trials (ACTs) - clinical trials of FDA-regulated products (drugs, devices, or biologics), as long as the trial is neither a feasibility study of a device prototype nor a phase 1 study of a drug. (Phase 1 studies usually evaluate safety, maximally tolerated dose, pharmacokinetics, etc.). To determine if your study is an ACT, click here. NIH-funded clinical trials – all clinical trials funded by NIH, wholly or in part, require registration and results reporting if the grant application was received by NIH on or after Jan. 18, 2017. Click here to determine if your study meets NIH's definition of a clinical trial. Clinical trials being considered for publication in ICMJE-affiliated journals must be registered on ClinicalTrials.gov before the first participant is enrolled. For more information on the International Committee of Medical Journal Editors’ (ICMJE) publication requirements, click here. PCORI-funded patient registries and clinical studies must be registered on ClinicalTrials.gov. For more information on Patient-Centered Outcomes Research Institute (PCORI) requirements for registration, click here. Your funding agency may have its own requirements; be sure to check the terms of your award letter. Who Is Responsible for Registering A Clinical Trial? The Responsible Party is responsible for ensuring the trial is registered and for promptly making updates as required by all applicable regulations and policies. Provided certain stipulations have been met, Montefiore and Einstein designate the main Principal Investigator (PI) as the Responsible Party for the following clinical trials: Trials in which the PI holds the IND/IDE (the PI is also considered the sponsor-investigator). Trials initiated by the Principal Investigator. NIH-sponsored trials for which Montefiore or Einstein is the grantee institution. Trials, initiated by private industry or other outside entities, for which the Principal Investigator accepts the role of the Responsible Party in an explicit agreement. When Must the Trial Be Registered? Montefiore and Einstein require registration on ClinicalTrials.gov of ACTs and NIH-funded trials prior to IRB approval. Elements of successful registrations include the following: The study record should not contain personal pronouns. Acronyms and abbreviations are spelled out the first time they are used in the record. The IRB# is listed as the Unique Protocol ID. Outcome Measures are measurable quantities (i.e. nouns). The description contains the name and description of the metric/scale used to measure the outcome measure. The timeframe for the assessment of the measurement must be discrete and specific. For a list of items that must be addressed before releasing the record to PRS review, see the Protocol Registration Quality Control Review Criteria. How Do I Register My Trial? To register your trial: Go to the ClinicalTrials.gov registration page Complete the login fields. In the “Organization” field, enter in the organization name, either “MontefioreMC” or “Albert_Einstein” Refer to the “User’s Guide” for additional information. As the PI, you are a “user” and you are responsible for entering the information about your trial, ensuring that the information is correct, and updating the information in a timely manner. On the Main Menu page, under Protocol Record, click on “Create” and complete the study description template. Note that the ClinicalTrials.gov-required fields are marked with a red asterisk (*) and the FDA-required fields are marked with a green FDAAA. These data elements represent the requirements for an adequate registration. If you do not complete these fields, your trial may not be considered “fully registered” Note also that each field of the template is labeled and linked to a definition. Several fields are potentially confusing and should be completed as follows: Organization’s Unique Protocol ID: Use the IRB number. This number can be found on any official IRB correspondence or by contacting irb@einsteinmed.org Record Verification Date: Enter the month and year on which you complete and submit the template. NOTE: This field generates automatic reminders – do not leave it blank Responsible Party: This should always be the Principal Investigator, even though the system defaults to “sponsor”. Sponsor: The database will default to “Montefiore Medical Center” or “Albert Einstein College of Medicine”. Although MMC/Einstein is not actually the financial sponsor, choose the default. Collaborators: Sponsorship can be clarified by entering the actual sponsor’s name. For unsponsored research, either leave the field blank or enter “None”. Oversight: For the Review Board, enter your IRB approval status and use the IRB number as the Approval Number. For the Phone, Email, and Address, use the IRB’s general contact information. Conditions: Use the MeSH controlled vocabulary (provided). If you do not, the ClinicalTrials.gov staff is likely to delete your term and choose one of their own. Keywords: Use the Use the MeSH controlled vocabulary (provided). If you do not, the ClinicalTrials.gov staff is likely to delete your term and choose one of their own. If the PI did not personally complete the template, send the draft template to him/her for review and approval. Note: This is an important step. The PI needs to have their own PRS user account and be listed as the Responsible Party for the study. If they are not in the system, email marina.tuzova@einstein.yu.edu as noted above under #2 to request an account. Submit the completed, PI-approved template by clicking on “Completed” at the top of the online template. Note: This means that you are done with the study record and is the only way the Einstein administrator knows to review and approve your study record. The completed template will go to the Einstein administrator. Note: the Einstein administrator does an administrative check on your study record to ensure the Sponsor section is accurate; the Einstein administrator does not review or correct any other content. Once complete, the Einstein administrator clicks on “Approve” at the top of the online template of the study record. The Principal Investigator must next release the template to ClinicalTrials.gov by clicking on “Release” at the top of the online template. The study record will be released to the PRS team. The PRS team will do their own quality assurance check. If they have no comments or changes, the study record will be published or updated on the ClinicalTrials.gov website in 2-5 business days. When Are Updates Required? Studies listed as recruiting on the ClinicalTrials.gov website need to be updated at least every six months, or more often if there are ANY changes to the information presented in the ClinicalTrials.gov study template, including changes in recruitment status, contact persons, etc. Updates can be made at any time, as needed. Updates are made in the Protocol Registration System (PRS) by the person who does the data entry on the study record. This person can be anyone who has access to the record but is typically the “owner” of the study record. How Do I Update A Study Record? Log in to https://register.clinicaltrials.gov/ using the organization name (MontefioreMC or Albert_Einstein), and your individual Username and Password. Locate the study and click on “Open” to view the record in more detail. Navigate to the section(s) you wish to update, open them, and edit the information. Ensure that all other information associated with the registration is current and accurate. Make sure to update the “Verification Date” in the Protocol Section under Study Status to reflect the current month and year that you completed your edit and review. The “Verification Date” is the field, which generates automatic reminders within the PRS system, and cannot be left blank. When done updating the record, please remember to hit “Entry Complete”, “Approved” and “Released” at the top of the template. In some instances, the Einstein PRS Administrator will be required to review and approve the study record prior to release. The Einstein PRS Administrator will follow up with you if this occurs. Once you click on “Entry Complete” the Einstein PRS administrator will get automatic notification of next steps and does not need any separate notification that your study is ready. The Einstein PRS administrator will send out emails to the PI and record owner if any areas of the study record are incomplete or if further action is required. Publication of the update takes between 2-5 business days because the PRS team does their own quality assurance check. Results Summary Data The Responsible Party is required to submit summary results data to ClinicalTrials.gov within 12 months of the primary completion date for ACTs, NIH-, and PCORI-funded studies. The results submission must include the following: Participant Flow Baseline Characteristics Outcome Measures and Statistical analyses Adverse Events All results information must be aggregated, summary level data. Do not include data for the individual participants. No written results or conclusions are allowed in the free-text fields. For detailed information on how to submit summary results data, click here. Templates are available from ClinicalTrials.gov or in the next section. Results Reporting Templates/Data Preparation Checklists Adverse Event Data Preparation Checklist Baseline Characteristics: Data Preparation Checklist Baseline Characteristics: Age Template Baseline Characteristics: Race, Ethnicity Template Baseline Characteristics: Sex/Gender Template Baseline Characteristics: Study Specific Measure Template Other (Not Including Serious) Adverse Events Template Outcome Measure Data Preparation Checklist Outcome Measure Results Reporting Template Participant Flow Data Preparation Checklist Participant Flow Template Serious Adverse Events Template Statistical Analysis Template Uploading Documents For trials with primary completion dates on or after January 18, 2017, the protocol and statistical analysis plan (SAP) must be uploaded to ClinicalTrials.gov. The protocol should be clear, concise, written in English and should clearly delineate the primary and secondary outcome measures. It must have a cover page with the official title, the NCT number and the protocol version date. Clinical trials which receive IRB approval after January 21, 2019 and are supported by federal funding must upload an unsigned copy of one of the Informed Consent Forms (ICF) used in the study. The ICF must be uploaded after the trial is closed to recruitment and no later than 60 days after the last study visit by any subject, as required by the protocol. Personal identifiable information, trade secrets, and confidential information should be redacted from all documents prior to uploading, unless such information is required by the regulation. The documents should all be converted to PDF/A (A=archivable) format. BEST PRACTICE: load all documents within 30 days after the last day of data collection (i.e. within 30 days after the study completion date). Helpful Resources Institutional Resources ClinicalTrials.gov Requirements for the Informed Consent Form Institutional Policy for Clinical Trials Registration and Results Reporting Institutional Plan for Dissemination of NIH-Funded Clinical Trials Tips for Registering Studies on ClinicalTrials.gov ClinicalTrials.gov Resources Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) Protocol Registration and Results System Protocol Registration Quality Control Review Criteria Results Quality Control Review Criteria Regulations and Support Materials Tutorial on Outcome Measures and Statistical Analyses in the Results Tutorials on Registration and Results Reporting ICMJE Resources ICMJE Publication: Requirements for Registration NIH Resources NIH Requirements for Registering & Results Reporting FDA NIH ICMJE Definition of Clinical Trial FDA Clinical Trial Definition NIH Definition of Clinical Trial ICMJE Definition of Clinical Trial Why Trials must be Registered? FDA’s Applicable Clinical Trials (ACTs) Checklist NIH checklist use NIH checklist Type of Intervention FDA-approved drug, device, or biologic Any Intervention Any Intervention Study Phase Any phase except phase 1 studies or device prototype feasibility studies Any and all phases (including pilot, phase 1, and feasibility studies) Any and all phases (including pilot, phase 1, and feasibility studies) Deadline for Registering Before IRB approval is granted (institutional policy) Before IRB approval is granted (institutional policy) Before first participant is enrolled (ICMJE’s policy) Results data required? YES YES Not required, but encouraged Does System prompt for results data? YES NO N/A Funding Source Any or no funding source NIH funding only Any or no funding source Penalty for non-compliance Monetary penalty up to $10,000/day for the duration of the violation Monetary penalty including withholding of grant funds Rejection of publication submission Required Fields Fields marked with * or *§ are required. Secondary ID (in Study Identification module) - enter grant# Collaborators (in Sponsor/Collaborators module) – enter funding center name IPD Sharing Statement - Starting Jan. 2019, the "Plan to Share IPD" field must be answered in the original registration. The answer must be YES or NO (Select NO if undecided). Click here for more information Questions about the ClinicalTrials.gov? Check out our FAQs page or contact us by email: ClinicalTrials.gov@einsteinmed.org or phone 718.430.2237 and ask to speak with a CT.gov specialist!