Official registry · BMU
Bangladesh Medical UniversityBMU CTR

PRS User's Guide

Section 1

Introduction

The BMU CTR Protocol Registration System (PRS) is a web-based tool used to submit clinical study information to BMU CTR. Records submitted through the PRS are available to the public at BMU CTR once they pass quality-control review. This document describes how to use the PRS and provides step-by-step instructions for PRS functions.

Additional information about applying for accounts, registering studies and submitting results, and support materials are available on the following pages:

Section 2

Record basics: steps to posting a study record on BMU CTR

  1. Description of Protocol Registration System Workflow

    Posting study information on BMU CTR is a multistep process

    1. Log in to PRS

      You will need to log in to an account linked to the Sponsor Organization of the study you want to register. Typically, the Sponsor Organization is the organization that initiates the study. To log in, enter your organization handle, username and password. For information on obtaining a PRS account, see How to Apply for an Account.

    2. Create a new record

      Create the record under your organization's PRS account. The record belongs to the organization, and other users in your organization's account can work on it.

    3. Enter (or edit) study information

      Provide information summarizing the study protocol, including the Brief Title, Study Type, Outcome Measures, Arms and Interventions, Eligibility Criteria, Contacts, and Study Site Locations. See the Protocol Registration Data Element Definitions and the Expanded Access Data Element Definitions for a complete list of required and optional data elements.

    4. Submit the study record for PRS Review

      • After all study information is entered, the person entering the information marks the record Entry Completed.
      • The Responsible Party for the study approves the record to accept the content.
      • The Responsible Party releases the record to submit it for review by the Registry Office. For more information about identifying the Responsible Party, see Section 3.2: Determining Who Should Submit a Record

    5. Registry Office staff review the record

      After the Responsible Party releases the record, Registry Office staff review it for apparent errors, deficiencies, and/or inconsistencies. This is a quality-control review only; it does not judge the scientific merit or the ethics of the study. If Registry Office staff find any potential issues with the record, they will add comments to the record and return it to you. The user must log in to PRS to view the comments, edit the study record to address them, and resubmit the record for PRS Review, using the same procedures described in steps 3 and 4.

    6. Record is registered and posted

      Once the study record passes PRS Review, it is published on the BMU CTR website and receives its permanent BMU CTR identifier (BDCTR ID), in the format BDCTR-YYYY-NNNNNN. Nothing is published until the review is passed. Once registered, a study record becomes a permanent part of BMU CTR and cannot be removed.

    7. Keep record up to date

      Update the study record whenever study information changes (as described in steps 3 and 4). Each update is an amendment that goes through the same review cycle, and every published version remains viewable in the record's History of changes.

    8. Add results

      When the study is complete, summary results can be entered in the PRS and submitted. Submitted results are reviewed by the Registry Office and then posted on the record as a new version. For more information, see How to Submit Your Results and Reporting Requirements.

  2. Record status

    As a record progresses through the PRS, its status changes, as described in Table 1.

    Table 1: PRS Record Status

    Record Status
    Record StatusDescription
    In ProgressUser is creating (or modifying) the record.
    Entry CompletedUser has finished data entry and marked the record Entry Completed. Record is ready for review by the Responsible Party.
    ApprovedThe Responsible Party has reviewed the record and approved it.
    ReleasedThe Responsible Party has submitted the record to BMU CTR by releasing it.
    PRS ReviewThe record is currently being reviewed by the Registry Office. The record is locked while PRS Review is being performed.
    PublicThe record has passed PRS Review and is posted (or updated) on the BMU CTR website.
Section 3

Accounts

  1. Overview: Roles and Responsibilities

    Anyone who enters clinical study information into the Protocol Registration and Results System (PRS) must have an account. There are several different types of accounts, and the type of account you have will depend on your role. For example, an organization (such as a company, university, or medical center) has an organization account. Each organization should designate one or more PRS Administrators to manage the account and create logins for additional users. Investigators affiliated with that organization or working on studies sponsored by that organization will be designated as users of this organization account. Table 2 shows different roles associated with the PRS and the responsibilities of each.

    Table 2: PRS Roles and Responsibilities

    PRS Role
    PRS RoleDescription and Responsibilities
    Sponsor OrganizationA company, university, medical center, or other research organization that conducts clinical trials. Each study record has a Sponsor Organization, and all PRS accounts associated with that record should be under the Sponsor Organization. Investigators apply to be users of the Sponsor Organization's PRS account. (If an investigator is conducting trials for more than one Sponsor Organization, he or she will need an account from each of those organizations to register the studies properly.)
    AdministratorIndividual designated by the organization to manage the organization's PRS account, create accounts for users, and serve as the point of contact for PRS Staff. All PRS organization accounts should have at least one Administrator who creates user accounts and oversees the maintenance of the organization's records. When the Sponsor is the Responsible Party (see below), Administrators are responsible for releasing records for PRS Review and posting to BMU CTR.
    UserAny PRS account holder who is authorized to enter information into the PRS, including investigators or research assistants. Users create and modify their own records, but cannot access other users' records unless authorized by the Record Owner or by an Administrator.
    Record OwnerPRS account holder who creates a study record in the PRS. Record Owners can maintain the record themselves or give one or more users access to a record to make changes. An Administrator can change the Record Owner after the record has been created.
    Responsible Party

    Entity or individual responsible for verifying the accuracy of a study record and releasing it to BMU CTR. The Responsible Party for a particular study may be the Sponsor, Sponsor-Investigator, or Principal Investigator. When the Responsible Party is the Sponsor, an Administrator performs these record functions.

    The person identified as the Responsible Party for the Sponsor Organization account acts as the official contact person for that account and full contact information for that person must be listed in the PRS account.

  2. Determining Who Should Submit a Record

    Before applying for a PRS account, you should make sure you're the appropriate person to submit clinical study information. Studies should be registered only by the Responsible Party, although other users can be authorized to add information to the study record either before or after a study is registered.

    To help you determine the appropriate Responsible Party for registering a study and submitting results, see the Responsible Party and Sponsor data element definitions.

    Each study generally has a Sponsor Organization. Studies must be registered under the Sponsor Organization's account. For example, if you are a Principal Investigator designated to be the Responsible Party for a study and you work for University X, but the Sponsor Organization for the study is University Y, the study must be registered under University Y, and you should set up your PRS account through University Y.

    A Contract/Clinical Research Organization (CRO) should not have its own organization account if they are not the responsible party for the studies they want to register. For each study a CRO intends to register, the CRO member will need a user account under the sponsoring organization's account. Note: it is very common for CRO members to possess several user accounts (one under each sponsoring organization), allowing the correct registration of study records sponsored by various institutions.

  3. Applying for an Account

    Most users will not apply for a PRS account directly with PRS, but will do so through the Sponsor Organization's PRS Administrator.

    If you do not know if the Sponsor Organization has a PRS account or who the Administrator is, follow the steps below:

    1. Check the current list of organizations with a PRS account to see if the Sponsor Organization is on the list.
    2. If the Sponsor Organization is on the list, submit a PRS Administrator Contact Request Form to PRS. You will receive contact information for the organization's PRS Administrator(s), whom you can contact directly to request a user login.
    3. If the Sponsor Organization is not on the list, this means the organization does not have a PRS account and must create one before you can register for a user account. You or the organization's management must identify someone to serve as the PRS Administrator for the organization and apply for a PRS organization account. If you are not sure who should be the organization's PRS Administrator, email the PRS Staff to help you identify an appropriate person. The Administrator will apply for the organization's PRS account. As part of that application, the Administrator provides his or her name, phone number, and email address. BMU CTR then creates both the organization's PRS account and the Administrator’s account and notifies the Administrator of his or her username and temporary password.
    4. Once the Sponsor Organization appears on the list of organizations with a PRS account, you can submit a request to the PRS Administrator to request a user login.

    Note: If the Sponsor Organization does not have an organization account or anyone who can serve as a PRS Administrator, you may apply for a PRS individual account. This option is not recommended for most organizations. After an individual account is created, an organization is still encouraged to identify appropriate individuals to act as PRS Administrators for the organization.

    PRS Staff will create a PRS account within 2 business days of receiving an application. Once the account has been created, you will receive an email with instructions for logging in to PRS.

  4. Changing User Account Information

    Update/Modify user information

    To change your PRS username, full name, or email address, follow the steps below:

    1. Log into the PRS and select Update [Username] User Account from My Account.
    2. Change the information that should be updated and select Save to activate the changes. You will receive an email notifying you of the change(s) after you save.

    Change password

    To change your PRS password follow the steps below:

    1. Log into the PRS and select Change Password from My Account.
    2. Enter the password information.
    3. Click on Change Password to save the new password.

    Find administrator information

    Your organization's Administrator can help answer questions about your account, record(s), or the PRS.

    To find your Administrator, log in to the PRS and see List Administrator(s) on My Account. You will then be presented with the contact information for each Administrator at your organization.

    It's a good idea to note your Administrator's contact information and keep it outside the PRS. The Administrator can reset your password if you forget it.

  5. Administrator Functions

    Administrators have three primary responsibilities:

    1. Maintain their organization's PRS account, including monitoring for problems with records
    2. Approve and release study records and updates when the Sponsor is the Responsible Party (see Section 4, Creating a New Record and Entering Data, for more information on this function).
    3. Serve as the primary point of contact with the BMU CTR team.

    Administrators can create and modify user accounts, designate other users as Administrators, and manage the organization's account. Administrator-only functions are on the User Accounts page, visible only to Administrators. The following are the steps for some Administrator functions:

    Create new user account

    1. Click on New User Account on the User Accounts page.
    2. Complete the fields:
      • Access Level: Choose Normal for users or Administrator
      • Username: Enter user login name (e.g., first initial plus last name).
      • Full User Name: Enter full first name followed by last name (Note: this information will be displayed publicly when the Investigator is the Responsible Party; ensure that the information is properly formatted and there are no spelling errors).
      • Other User Information: Enter additional information about the user (include phone number to make it easier to contact the user).
      • User Email: Enter email address of user.
      • Send optional (PRS-generated) email messages: This is checked by default. Administrators may uncheck to eliminate email notifications when users complete data entry for records or reset records to in-progress (not recommended).
    3. Click on Register to accept account information and generate automatic email notification to the user of the new account.

    Update/Modify User Account Information

    1. Click on Modify next to the username for the account to be updated.
    2. Enter changes on the User Information page.
    3. Click Save.

    Change User Password

    1. Click on Reset Password next to the username for which the password is to be reset.
    2. Enter and confirm a new password.
    3. Click on Reset Password. The new password will be emailed automatically to the user.

    Disable/Enable User Account

    1. Click on Disable (or Enable) next to the username corresponding to the account to be enabled/disabled.
    2. Select a new user to transfer ownership of the user's record(s).
    3. Click on Disable (or Enable) to confirm the operation.
Section 4

Creating a new record and entering data

This section describes the steps to creating a new record and entering data.

To register a study, you will first need to create a record in the PRS and enter information about the study. When entering information into your record, you will need to complete a series of topic-specific sections. All information entered may be modified later. For more information on the required and optional data elements needed to provide summary protocol and results information, see the Protocol Registration Data Element Definitions, Expanded Access Data Element Definitions, and Results Data Element Definitions.

  1. How to Create a New Record

    Records are created and entered directly in the web PRS. A record may be created in a single session or created and saved for completion at later sessions. To create a record:

    1. New Record

      From the PRS, go to your organization's list of study records and start a new record.

    2. Enter the basic identifying information

      Enter the Unique Protocol ID, Brief Title, and Study Type (interventional, observational, or expanded access) for your record. Note: The Unique Protocol ID may be assigned by your organization. If the study has not been assigned a Unique Protocol ID, please use another unique identifier for your record, such as your ethics committee approval number.

    3. Complete each section of the record

      Work through each section of the record form (for example, study identification, design, conditions, interventions, arms, eligibility, sponsor and contacts, outcome measures, dates and oversight). For each arm of the study, add an arm and fill in its data.

    4. Save your work

      Save the record regularly. You can stop at any time and return later to continue editing your record; see Section 7: Modifying a Record.

    5. Follow instructions in Section 5

      When all sections are complete, follow the instructions in Section 5: Preparing, Approving, and Releasing a Study Record.

  2. Data Entry Tips

    1. Formatting Text

      • For multi-line text fields in the PRS, the following conventions help keep paragraphs and lists readable.
      • To format paragraphs, include a blank line between paragraphs.

      • To format bulleted lists, start each list item on a new line with a "list item" character, such as a hyphen (-) or an asterisk (*), followed by a space and then the item text. Follow the list with a blank line, to add a paragraph following the list. For example:

        First paragraph.
        • list item one
        • list item two
        Next paragraph.
      • To format numbered lists use sequential numbers, starting with "1" (or "1."), as the list item characters. Alternatively, use lower case letters, starting with "a.", as list item characters.

      • Bulleted, numbered and lettered lists may be combined in order to create a list within a list. For example:

        • list item one
          1. list item 1a
          2. list item 1b
            • bullet one
            • bullet two
        • list item two
        ...

    2. Formatting Eligibility Criteria

      Eligibility Criteria should be entered with a header for Inclusion Criteria and a header for Exclusion Criteria. Each criterion is entered below the header using a bulleted list like this:

      Inclusion Criteria:
      • item
      Exclusion Criteria:
      • item
      • Put each eligibility item on a separate line. Press the Enter key after entering text for each line.
      • Start each line of a bulleted list with a hyphen and a space ( - ) before entering the text.
      • If necessary, combine bulleted, numbered, and lettered lists in order to create lists within a list, as shown above.

    3. Special Characters

      The standard character set for BMU CTR is Unicode, with UTF-8 encoding. When you access the PRS website, your web browser is automatically set for UTF-8, so typically no adjustments are required.

      Problems with special characters (for example, symbols or non-English letters) most often occur when text is copied from a document that was created with a character encoding scheme other than UTF-8, and pasted directly into a field in the PRS. Most of the characters look fine, while certain special characters are invisible or are replaced with a character other than the one intended.

      On a Windows PC, the Character Map accessory can be used to insert special characters that are not found on the keyboard. Other computer systems usually provide a similar tool.

      These commonly used special characters can be copied from this page and pasted into PRS data entry fields:≤ ≥ ° ± µ ™ ®

      When using copy/paste to enter protocol information, review the text entered into the record carefully. In general, if you can see the correct characters in the fields within the PRS, the encoding is correct.

  3. Optional versus Required Fields

    BMU CTR requires certain data elements to be entered before the record can be submitted for PRS Review and posting. Optional fields are not required for posting on BMU CTR, but may be required to meet the requirements of other organizations (such as ethics committees, medical journals or funding sources). You should verify any requirements by your institution and any external organizations that may be using the study record.

    For information on the required and optional data elements needed to provide summary protocol and results information, see the Protocol Registration Data Element Definitions, Expanded Access Data Element Definitions, and Results Data Element Definitions.

  4. System Validation Messages: Missing Required Information

    The PRS checks the record for the minimum required information and shows a checklist of anything still missing. Information in one section may affect what is required in another, so you may need to correct or add information in different sections to complete the checklist.

    A record cannot be marked Entry Completed until all required information has been entered. Beyond the required minimum, review the record carefully against the review criteria (see Section 5.1.1); items that are not addressed may lead to comments during PRS Review.

  5. Record Access

    Study records belong to the organization account under which they were created. Users of that organization's PRS account can find the organization's records in the PRS and add or modify information while a record is editable.

Section 5

Preparing, approving, and releasing a study record

Before releasing a record to the Registry Office for review, read it over carefully to make sure it is accurate, complete, and free of errors. Here are steps to follow and tools you can use to prepare and release your record.

  1. Data Entry Review

    Look your record over carefully to ensure that it does not contain spelling or other mistakes, and check that it is formatted correctly and clearly. Check that the Brief Title and Brief Summary will be easily understood by website users, and that all acronyms are spelled out on first mention (for example, Bangladesh Medical University (BMU)).

    1. PRS Review Criteria

      Registry Office staff rely on two sets of criteria when reviewing summary protocol and results information in study records:

      It is strongly recommended that you check these criteria against your study record.

  2. Approving a Record

    The Approval process differs depending on the Sponsor Organization or Responsible Party for the study record. If the Responsible Party is the Sponsor, an Administrator—acting as the agent of the Sponsor Organization—approves records. If the Principal Investigator or Sponsor-Investigator is the Responsible Party, the Principal Investigator must approve the record.

    A record must be approved before it can be released to the Registry Office for PRS Review.

    1. How to Submit a Record for Approval

      When you have entered information for all the sections of the record, you are ready to submit the record for approval.

      1. Open the record you wish to submit from your organization's list of study records.
      2. Review the record and make any necessary changes. Make sure no required information is missing (see Section 4.4: System Validation Messages).
      3. Mark the record Entry Completed. The record is now ready for review by the Responsible Party. If you need to make further changes before it is approved, you can return the record to In Progress.

      The Responsible Party will review the record. Once approved, the Responsible Party can also release the record to the Registry Office for review.

    2. How to Approve a Record for Release

      The process is the same no matter who is responsible for approving and releasing the record:

      1. Find records with the status Entry Completed in your organization's list of study records.
      2. Open the record.
      3. Review the record by following steps described in Section 5.1: Data Entry Review.
      4. Approve the record.

  3. Releasing a Record

    After the record is approved, the last step is for the Responsible Party to release it for PRS Review.

    When a Principal Investigator or Sponsor-Investigator is designated as the Responsible Party for a record, it is the Principal Investigator or Sponsor-Investigator who must release the record for PRS Review. When the Sponsor is designated as the Responsible Party for a record, an Administrator must release the record.

    The steps are the same whether an Administrator, Principal Investigator, or Sponsor-Investigator must release the record:

    1. Open the approved record from your organization's list of study records.
    2. Review the record for accuracy.
    3. Release the record to submit it to BMU CTR for PRS Review.

    After a record is released, it undergoes PRS Review. If the Registry Office requires further changes, the record is returned so changes can be made, and the record must be completed, approved and released again. If the record meets the review criteria, it is posted on the BMU CTR website and is available to the public.

  4. Past Versions

    1. Viewing Past Versions

      Every published version of a record is kept. Anyone can view earlier versions of a public record in the History of changes section of the study record on BMU CTR.

Section 6

Registry review process

Anytime the Responsible Party releases a study record, Registry Office staff will review it for apparent errors, deficiencies, and/or inconsistencies based on the Protocol Review Criteria and the Results Review Criteria.

PRS Review is a quality-control review only. It does not judge the scientific merit or the ethics of the study; ethics approval is given by an external ethics committee and recorded on the record.

If Registry Office staff identify potential issues with the study record, they will add comments to your record. Comments identified as Major Comments must be corrected or addressed. Comments identified as Advisory Comments are suggestions that should be considered to improve the clarity of the record.

Studies will not be posted until all Major Comments have been addressed and the record passes PRS Review. This applies to all records, including results.

The Major Comments List contains the brief, standard portion of all Major Comments that may be provided to the responsible party during PRS Review. This list is updated as Major Comments are added or retired from use.

The Responsible Party must ensure Major Comments are addressed within 15 calendar days of the date on which the Registry Office returned the record.

If you have questions about PRS Review comments, contact the Registry Office.

  1. Identifying Records with Review Comments

    When the Registry Office returns a record with comments, the record goes back to In Progress and you are notified in the PRS. Check your organization's list of study records for records that have been returned. A returned record must be corrected and completed, approved and released again to be processed for review and posting on the BMU CTR website.

  2. View Review Comments

    To read PRS Review comments, open the relevant record in the PRS. The comments, each marked as Major or Advisory, are shown with the record so you can address them while editing.

  3. Editing a Record with Review Comments

    If you need to edit your record after receiving PRS Review comments, follow these steps:

    1. Open the returned record from your organization's list of study records.
    2. Read the comments and edit the record to address each Major Comment (and any Advisory Comments you choose to act on).
    3. Mark the record Entry Completed.
    4. The Responsible Party approves and releases the record to submit it to BMU CTR for PRS Review (see Section 5).
Section 7

Updating and maintaining records

Once a record is created, you will need to modify it occasionally to make edits, update information, and enter results. This section discusses how to modify an existing record, as well as some other functions related to record maintenance.

  1. Modifying a Record

    A record can be edited while it is In Progress or Entry Completed. Once it has been approved and released, it is locked until PRS Review is complete or the record is returned to you.

    1. Editing a record that has not yet been published

      1. Open the record from your organization's list of study records.
      2. Make changes as needed in each section and save.
      3. Follow the steps to complete, approve and release your record (see Section 5).

    2. Updating a published record (amendment)

      1. Open the public record in the PRS and start an amendment. The record returns to In Progress for editing.
      2. Make changes as needed and save. While you work, the last published version stays visible on BMU CTR.
      3. Complete, approve and release the amended record. It goes through PRS Review like any other release.
      4. When the amendment passes review, it is posted as a new version of the record under the same BDCTR ID. Earlier versions remain viewable in the record's History of changes.

      See also How to Edit Your Study Record.

  2. Entering Results

    When the study is complete, open the record in the PRS and enter its summary results. Results are entered for the outcome measures listed in the record. When the results are ready, submit them; the Registry Office reviews them against the Results Review Criteria, and once they pass review they are posted on the record as a new version. See How to Submit Your Results.

  3. Records and Changes of Sponsor

    Records are registered under their sponsoring organization's account. Therefore, a sponsored study must stay in the account of its sponsor even if/when an associated investigator leaves that institution. If the Sponsor of a study has changed, contact the Registry Office for advice.

Section 8

Problems with records and how to resolve

Several kinds of issues can leave a record stuck or out of date. This section describes common problems with study records and how to resolve them.

Monitor the status of your organization's records in the PRS to identify any records that need attention.

Once you have addressed the problem by editing the study record as directed, the Responsible Party (an Administrator, Sponsor-Investigator, or Principal Investigator) must release the record for PRS Review again.

  1. Identifying and Resolving Records with Problems

    Follow the steps identified in Table 3 and Table 4 to address each problem.

    When problems occur, they usually fall into two main categories:

    • Data Entry Problems
    • PRS Administrator Problems

    Note: The Responsible Party (an Administrator or Principal Investigator) must release a study record whenever it is modified for the changes to appear on BMU CTR.

    1. Data Entry Problems

      Consult Table 3 for a list of common Data Entry Problems, along with their solutions.

      Table 3: Data Entry Problems

      Data Entry Problems
      Data Entry ProblemsSolution
      Pending PRS Review Comments
      • Potential issues were identified during PRS Review and the record was returned.
      • Major Comments must be addressed within 15 days and the record released again for the record to be processed for posting on the BMU CTR website.
      		User:
      • Open the record and read the review comments.
      • Modify the record as needed to address the comments.
      • Mark the record Entry Completed.
      Administrator/Responsible Party:
      Entry Not Completed
      • The record has been created or modified, but it has not been marked as Entry Completed.
      • A record must be marked as completed, approved, and released before it can be reviewed by the Registry Office and made public (or updated) on the BMU CTR website.
      		User:
      • Review the record and modify it if necessary.
      • Mark the record Entry Completed.
      Administrator/Responsible Party:
      Not Recently Updated
      • The record has not been recently updated.
      • This applies only to active studies, with an Overall Recruitment Status other than Completed, Terminated, or Withdrawn.
      • Changes in recruitment status should be reported within 30 days, and other information should be reviewed and updated at least once every 12 months (see Section 9: Terms and Conditions).
      		User:
      • Start an amendment, review the record for accuracy and modify it as needed.
      • Mark the record Entry Completed.
      Administrator/Responsible Party:
      Record Is Missing Required Information
      • The completeness check lists one or more required items that have not been entered.

      Note that information can become out of date due to the passage of time (for example, an anticipated Primary Completion Date in the past).

      		User:
      • Modify the record as needed to supply the missing information.
      • Mark the record Entry Completed.
      Administrator/Responsible Party:

    2. PRS Administrator Problems

      Some problems on records can be resolved only by an Administrator or the Responsible Party, although the user who entered the record may need to get involved, too. These PRS Administrator Problems are described in the following table.

      Table 4: PRS Administrator Problems

      PRS ADMIN Problem
      PRS ADMIN ProblemSolution
      Ready for Review and Approval
      • A user has marked a record as Entry Completed following the initial data entry or modification of the record. The record is ready to be approved and released for PRS Review and to be made public on the BMU CTR website.
      		Administrator/Responsible Party:
      Never Released
      • A record has been created, but has never been released.
      • A record must be marked as completed, approved, and released before it can be reviewed by the Registry Office and made public (or updated) on the BMU CTR website.
      		Administrator/Responsible Party:
      • Determine whether the study should be posted on BMU CTR and who should finish data entry.
      User:
      • Finish initial data entry or update the record, as appropriate.
      • Mark the record Entry Completed.
      Administrator/Responsible Party:
      Update Not Released
      • A record that has been posted on BMU CTR has an amendment in progress, but the amendment has not been released.
      • An amendment must be marked as completed, approved, and released before it can be reviewed by the Registry Office and posted on the BMU CTR website. Until then, the public record shows the last published version.
      		Administrator/Responsible Party:
      • Determine who should finish updating the record.
      User:
      • Review and update the record, as appropriate.
      • Mark the record Entry Completed.
      Administrator/Responsible Party:
Section 9

Terms and conditions

Organizations and individuals submitting information to the PRS must agree to the following Terms and Conditions:

  • Only studies that conform to applicable human subjects or ethics review regulations (or equivalent) and applicable regulations of the national (or regional) health authority (or equivalent) may be submitted.
  • Notice of changes in recruitment status must be provided as soon as possible, but no later than 30 days after such changes. All other submitted information must be reviewed, verified, and updated as necessary and no less than every 12 months.
  • The submitting organization, or individual designated as the Responsible Party, is responsible for the completeness and accuracy of the information submitted to the PRS.
  • Study information must be submitted in English.
  • Multiple groups within a single entity (for example, a company, university, government agency) must share a single PRS organization account.
  • Previous versions of study information will be available to the public, although the default view will be the most recent version.