Registration of Clinical Trials on ClinicalTrials.gov
December 2019
Purpose:
The purpose of this guideline is to provide guidance for Johns Hopkins Medicine (JHM) investigators and study teams with clinical trials registration and results reporting on ClinicalTrials.gov. Additionally, this guideline offers guidance for posting of clinical trial consent forms for federally funded clinical trials on ClinicalTrials.gov.
JHM ClinicalTrials.gov Program
The Institute for Clinical and Translational Research has a Program to assist study teams with ClinicalTrials.gov-related processes such as;
- The ethical, scientific and legal reasons for clinical trials registration and reporting
- Which trials are required to be registered and the timelines
- Tips, tricks and helpful content to improve the registration and results reporting
- Up-to-date information on institutional and federal policies
- Direct effort upon request (billable per hour)
The Johns Hopkins ClinicalTrials.gov Program can be reached at [email protected]. Additional resources can be found on the Program’s website at https://ictr.johnshopkins.edu/programs_resources/clinicaltrials-gov-program/
I. Initial Study Registration
Trials requiring registration in accordance with 103.25 Organization Policy on Registration of Clinical Trials, should be submitted to ClinicalTrials.gov concurrently with initial IRB submission. Concurrent submission recognizes that registration is a process which requires review and potential comments prior to public release from the ClinicalTrials.gov Protocol Registration and Results System (PRS) Review Team.
Guidelines for Initial Registration
A training video is available to walk investigators through the registration process. There is also a checklist investigators can use for this purpose which can be found at https://ictr.johnshopkins.edu/wp-content/uploads/CTgov-QCChecklist.docx
User Accounts
- New user accounts can be requested from the Johns Hopkins ClinicalTrials.gov Program
- Any personnel who will be creating, editing or accessing a record within the PRS Account will be required to have his or her own individual account.
- Account sharing is not permitted.
Assigning roles within the PRS
“Record Owner”
If someone other than the PI creates a record, as part of the review, the Johns Hopkins ClinicalTrials.gov Program will designate the PI as the Record Owner and add the record creator to the “Access List”.
“Responsible Party”
Assigning the “Sponsor” as the Responsible Party allows for the Johns Hopkins ClinicalTrials.gov Program to review records for common errors prior to being released.
Completing the “Oversight” section in ClinicalTrials.gov
Reflect accurate information pertaining to the following fields:
- Status: select current status (e.g. “Request not yet submitted”, “Submitted, pending”, “Submitted, approved”)
- Approval Number: IRB Number
- Board Name: Johns Hopkins Medicine Institutional Review Board
- Board Affiliation: Johns Hopkins Medicine
- Board Contact:
- Business Phone: 410-502-2092
- Business e-mail: [email protected]
- Address: 733 N. Broadway, MRB 117, Baltimore, MD 21205
The National Clinical Trial (NCT) number should be listed on the initial IRB application. Should the trial be submitted to the IRB without the NCT number, the PI or member of the study team must update the NCT number as soon as the number is assigned by ClinicalTrials.gov. Updating the NCT number is done through an administrative action (“Admin Changes”) and does not require a change in research application. The Admin Changes function may not be available when there is a pending change in research.
II. Updating Records
Changes requiring Prompt Updating:
There are several data elements that need to be updated within 30 days. [See policy]. At the time of any change in research or protocol amendment, the ClinicalTrials.gov record may need to be updated accordingly. It may be helpful to have the study team members involved in the IRB correspondence also be involved in updating the record in ClinicalTrials.gov.
Once the update is complete, the record must be marked as “Entry Complete” in the PRS for an administrator to review and release for public posting.
Annual Verification
Each record must be reviewed and verified at least once every 12 months even if there are no changes. At the time of the annual verification, you should review each protocol module for accuracy and ensure any protocol amendments or any changes to informed consent are reflected, if applicable. Confirm completion dates listed are accurate.
Once the review is complete, the record must be marked as “Entry Complete” in the PRS for an administrator to review and release for public posting.
Once posted, it will be helpful to set reminders to verify records within the 12-month requirement.
III. Submission of Results
A training video is available to walk investigators through the results reporting process. There is also a checklist investigators can use for this purpose which can be found at https://ictr.johnshopkins.edu/wp-content/uploads/CTgov-QCChecklist.docx
ClinicalTrials.gov estimates up to 40 hours may be needed to enter results. Since results are due within 12 months of completion dates, we recommend beginning results entry months ahead. It may take a couple of weeks for formal review of results after submission and you may be required to respond to reviewer comments. The Johns Hopkins ClinicalTrials.gov Program may send the PI reminder emails 3-4 months in advance of due date.
JHM 103.25 Organization Policy on Registration of Clinical Trials specifies the types of clinical trials that require results reporting. Investigators are however not limited and may choose to report the results of any clinical trial on a voluntary basis.
Important tips when uploading documents to ClinicalTrials.gov:
The PI must ensure that the informed consent form is uploaded to ClinicalTrials.gov, no later than 60 days after the last study visit by any subject, as required by the protocol. The latest IRB-approved consent form can be accessed from the “Stamped Document” section in the eIRB.
The protocol and statistical analysis plan must be uploaded at the time of results submission. The latest IRB-approved protocol can be accessed from the “View Application” link on the study’s dashboard in eIRB
Only the most recent IRB-approved study documents should be uploaded and a cover page should be included with each document as follows:
- The “Document Date” in the PRS must match the date on the uploaded document
- All uploaded documents should include a cover page with the following elements
- Official title
- Date
- NCT number
- All uploaded documents should be in PDF/A format
Definitions:
Access List: A list of account holders within the PRS that are granted access to a study. A user granted access to a record in this manner can perform all of the same actions on the record as if they were the record owner, with the exception of modifying the Record Access List.
NCT Number: The National Clinical Trial number is an identification that ClinicalTrials.gov assigns a study when it is registered. The NCT number is in the format “NCTXXXXXXXX”. Until an NCT number is assigned, the study is not registered.
PRS: The Protocol Registration and Results System is the online system that allows account holders within the institution to register, update and report results on ClinicalTrials.gov. The PRS can be accessed at https://register.clinicaltrials.gov. JHM maintains separate PRS accounts for “JohnsHopkinsU”, “SKCCC”, “KennedyKrieger” and “JHSPH”
Record Owner: Any account holder that creates a new record is automatically assigned as the Record Owner. The Record Owner will receive periodic emails from ClinicalTrials.gov whenever there are problems that require attention.
Responsible Party: The sponsor of the clinical study, as defined in 21 CFR 50.3; or the principal investigator of such clinical study if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the study, has access to and control over the data from the clinical study, has the right to publish the results of the study, and has the ability to meet all of the requirements for the submission of clinical study information. For a pediatric postmarket surveillance of a device product that is not a clinical trial, the responsible party is the entity who FDA orders to conduct the pediatric postmarket surveillance of the device product.
The sponsor may designate a principal investigator as the responsible party if such principal investigator meets all of the following requirements: is responsible for conducting the study; has access to and control over the data from the study; has the right to publish the results of the study; and has the ability to meet all of the requirements for submitting and updating clinical study information.
Secondary ID: Any identifier(s), other than the organization's Unique Protocol ID or the NCT number that is assigned to the clinical study. This includes any unique clinical study identifiers assigned by other publicly available clinical trial registries. If the clinical study is funded in whole or in part by a U.S. Federal Government agency, the complete grant or contract number must be submitted as a Secondary ID.
Sponsor: The entity (for example, corporation or agency) that initiates the study
Unique Protocol ID: Any unique identifier (ID) assigned to the protocol by the sponsor. At JHM, the Unique Protocol ID is the IRB number.
Related Resources:
University Policies/Guidelines:
Posting of Consent Forms for Federally-Funded Clinical Trials
https://www.hopkinsmedicine.org/institutional_review_board/guidelines_policies/guidelines/posting_cf_federally_funded_clinical_trials.html
103.25 Organization Policy on Registration of Clinical Trials