How to Register a Clinical Trial on ClinicalTrials.gov

Contents

The Protocol Registration and Results System (PRS)

Clinical trials are registered on the鈥�痵ite through a web-based data entry system called the鈥�. Some terms used in relation to accounts in the PRS include:

  • Organizational account. An organization (e.g., the UW) has a single PRS organizational account. The 91探花account is called鈥�UWashington.
  • Organization account manager. 罢丑别鈥�UWashington鈥痑ccount is managed by HSD鈥檚 Regulatory Affairs team.
  • Individual user accounts. Researchers or their staff must set up鈥�user accounts鈥痶hrough the organization account. An individual鈥檚 user account may be used for more than one clinical trial.

Who Can Use The 91探花PRS Organizational account

Any 91探花faculty, staff or student who is eligible to use the 91探花IRB鈥� for review of their studies may use the 91探花account to register clinical trials in which the 91探花is engaged in the research, even for trials that were reviewed by a non- 91探花IRB instead of the 91探花IRB.

Creating a User Account

To create your user account, following the instructions outlined in the SOP Creating a CT.gov User Account. Requests for a new user account are usually completed within 2 business days once the Regulatory Affairs team receives the request.

General Help Documents to Get Started in the PRS

To assist researchers, HSD has linked to CT.gov Quick Overview Guides from the PRS site.

  • PRS Quick Overview Guides
  • : 28-pages of step-by-step instructions for how to use PRS

PRS Roles and Responsibilities

General information on different PRS roles and responsibilities can be found in section 3.1 of the . The following provides UW-specific information:

Sponsor (or Sponsor Organization) – The 91探花is a Sponsor Organization; it is listed in the PRS system as鈥�UWashington.

Administrator – HSD鈥檚 Regulatory Affairs team serves as the Administrator for the UWashington account.鈥疌ontact them through鈥�hsdreprt@uw.edu.

Responsible Party – The 91探花PI should be identified as the Responsible Party for studies reviewed by HSD. For studies managed under the Fred Hutch/ 91探花Cancer Consortium, a PI who initiates or conducts an investigator-initiated clinical trial is designated as the Responsible Party, but the Responsible Party for other types of interventional trials is usually the Sponsor.

Registering a Trial

HSD reviews all incoming IRB applications and certain study modifications to determine whether the study is required to register and report results on CT.gov. The Regulatory Affairs staff at HSD will send an email to the study team if the trial meets these requirements and outline the steps for completing registration.

If the study is required to register in PRS, Regulatory Affairs staff will initiate the trial registration for the PI in PRS. The PI will need to complete the registration in PRS no later than 21 days after enrollment of the first study participant or within 1 year of IRB approval (HSD Policy), whichever occurs first. Registration is completed when a National Clinical Trial (NCT) number has been assigned to the study record.

Generally, each IRB application will have its own PRS study registration. However, contact HSD at鈥�hsdreprt@uw.edu鈥痳egarding unique situations that may require more than one study registration for a study (e.g., NIH requests two separate registrations). Include 鈥�CT.gov鈥欌�痠n the subject line of your email to help triage your message efficiently.

Registration Data Entry

After receiving the email from the Regulatory Affairs staff regarding initiation of trial registration, log into the to enter data and complete registration. Information is entered by the study team in the trial record by completing a series of topic-specific sections (called modules) in the 鈥楶rotocol Section鈥� located on the 鈥楻ecord Summary鈥� page.

The following documents and links provide guidance and instructions on how to enter data into the modules:

  • WORKSHEET Clinical Trial Registration鈥痺as prepared by HSD for researchers. It lists the protocol modules and the specific data elements in each module. This allows the record creator to see in advance what specific information will be required, before going into the PRS system.

Additional resources from CT.gov:

  • CT.gov PRS
    • Review section 鈥淩egistration Tutorials鈥� which describes how to enter data in each individual module.
  • CT.gov
  • . This PRS webpage provides definitions for each of the protocol registration data elements and indicates whether each element is required.
  • 鈥痙escribes the criteria used by the PRS system to assess completeness and consistency of results reporting.

Helpful Tips

  • Smart forms. The PRS data entry forms are 鈥渟mart鈥�. This means that some fields will appear (or not) depending upon your answers to other questions.
  • Optional elements. A symbol, as described in the , and shown below, indicates whether each data element is optional or required.

PRS optional elements diagram showing symbols that indicate whether a question is required

  • Special characters, formatting tips. See 4.2 Data Entry Tips in the for help on formatting and using special character information (e.g., example: 鈮� or 卤).
  • One or multiple sessions. You do not need to complete the registration in one sitting. Use the save option at the bottom of the section where you are entering information before navigating away. When ready, log back in and return to any remaining sections to complete the registration.
  • Downloading a copy of the record. Section 5.1 of the describes how to download an RTF file of your record. This can then be imported into Microsoft Word (or another word processing program) 鈥� which is very useful for editing and sharing a record with co-workers.
  • HIGHLY RECOMMENDED: Review what you have entered before you submit the record. Section 5.1 of the describes several different ways to check your record. The document is also useful.

Resolving Problems

Section 8 of the describes how to identify and resolve records with problems.

For specific questions related to data entry or registration issues for your specific trial, we recommend contacting register@clinicaltrials.gov for assistance.

For general questions, contact HSD at hsdreprt@uw.edu for assistance. Include 鈥�颁罢.驳辞惫鈥� in the subject line of your email to help triage your message efficiently.

For assistance with studies managed by the Cancer Consortium鈥檚 Clinical Research Support (CRS) Office, contact CRS at CTgov@fredhutch.org. More information can also be found on the .