RDCRN Policies and Procedures Documentation

Information on the RDCRN Policies and Procedures can be found here: RDCRN Policies and Procedures

Regulatory Platform Training

The RDCRN offers consortia an FDA 21 Part 11 compliant eRegulatory platform. Switching to an eRegulatory platform from paper-based ISFs creates a web-based system that allows effortless creation, management, and sharing of essential regulatory documents. Logs and documents can be signed electronically, compliant with Part 11.

Consortium PM Quarterly Meetings and RDCRN Steering Committee Meetings

RDCRN Steering Committee meetings are held monthly on Tuesdays at 12pm Eastern Time. Attendees include consortium principal investigators, consortium project managers, DMCC principal investigators and project managers, and NIH program officers. Contact your DMCC project manager to receive the calendar invitation.

RDCRN Project Manager meetings are held quarterly (days/times vary). They cover topics relevant to all project managers across the network. Contact your DMCC project manager to receive the calendar invitation.

Using the Permissions Dashboard

The RDCRN Permissions Dashboard website displays RDCRN member accounts and their permissions within the RDCRN suite of tools, websites, and services. Select RDCRN users can view and make changes to RDCRN member accounts. Learn more:

RDCRN Permissions Dashboard

Getting Oriented with RDCRN Box

Access Box at https://Box.RDCRN.org

Get acquainted with RDCRN Box by watching the RDCRN-specific Box Orientation under “Resources” on the Members Landing Page. Here you will learn the ins and outs of Box and how to optimize your Box usage.

Reference https://rdcrn.atlassian.net/l/cp/GELLm1wC for information on the Box folder security levels (green, blue, red) and requesting the creation of a new high-level folder.

Navigating RDCRN Box

All RDCRN members have access to the following folders:

• All Consortia

  • Regulatory Central: protocol and MOP templates, regulatory guidance, DMCC protocol review process

  • Policies and Procedures

  • Data Use and Data Sharing

  • Committee folders

• Brand Central

  • RDCRN-branded logos and templates, core slide decks, promotional material

Consortium-specific members have access to:

• Consortium-specific folder

  • Users identified as “consortium management” have write access to this folder and decide what is saved there/ what it is used for

  • All users associated with the consortium have read access to this folder

• Consortium-specific Secure folder

  • This is a PHI-safe folder where standard and custom reports and datasets are stored

  • Only users specified by the consortium managers have read access to this folder

Protocol Review Process

Each RDCRN protocol follows a standard review process. The consortium project manager is responsible for notifying the DMCC of any protocol updates. A flow chart of the standard review process can be found here:

RDCRN Protocol Review & Approval Process Flow Chart

Pilot protocols are not required to be reviewed, but can be reviewed if requested.

More information on the Protocol Review Process can be found in the RDCRN Policies and Procedures document.

Protocol Database Maintenance and Updates

The RDCRN Protocol Database website is accessible to all RDCRN members at https://protocols.rarediseasesnetwork.org/. This website contains basic information about all RDCRN Protocols. The information collected on this website is used for reporting and to display on the public website (https://www.rarediseasesnetwork.org) so it is critical to keep this information correct and up-to-date. Learn more:

RDCRN Protocol Database website

Data Management (DM) Processes and Guidance Documentation

Questions related to data management processes should be routed through the Data Manager assigned to the Consortium.

Key DM Topics:

Database build timeline

As each study is unique and may have different requirements, be sure to involve your Data Manager (DM) as soon as possible at the beginning of study planning and protocol development. The Data Manager can bring context, identify potential risks for data collection, and meaningful discussion related to the expectations of the protocol allowing for the study to team address these concerns prior to the finalization of the study protocol and potentially prevent future amendments.

REDCap Database Build Flow Chart

Data Management Plans (DMP) and Data Quality Plans (DQP)

DMPs and DQPs will be drafted by the DMCC for each study protocol. There is an expectation that the study team will be involved in the review of these documents and provide feedback and, ultimately, approval. These documents play a key role in ensuring the accuracy, integrity, and consistency of the collected study data.

Database Lock

Processes are in place for when a study is nearing completion including ensuring all expected study data have been entered into the study database, that these data have been reviewed, and that discrepancies defined in study data quality plans have been addressed. Please reach out to your study’s Data Manager to determine the necessary activities to be completed as each study may have different requirements for determining when the study database can be locked.

Handling duplicate participants and patient transfers in databases

As the requirements and scenarios related to duplication of enrollment, duplicate data entry, and subject record site transfers for each study vary it will be necessary to work with the study Data Manager to determine the appropriate course of action. These processes should be outlined in the study’s manual of procedures and the Data Management team will document any data modifications made to a record by the DMCC in the study’s Data Quality Plan.

Study Monitor Access to RDCRN Tools

Please refer to the standard operating procedure that addresses many of the questions related to study monitor access to different RDCRN tools and databases. It refers to Complion eRegulatory access (and will soon be updated to address the Florence platform). It also outlines how monitors can issue/resolve queries in study databases.

Checking Moodle Grades

Basic information on the Moodle Training platform can be found here: RDCRN Training Software - Moodle

A consortium’s administrative core team may wish to review training records for their members. To do so, request “Teacher” access to your consortium’s courses by submitting a HelpDesk ticket here.

With “Teacher” access, navigate to a course’s Grader Report:

Open

From the Grader Report, search by user’s name to locate the training records for a consortium member:

Open

New Site Additions

When consortia want to add new sites not included in the original grant application they are required to get approval from the NIH. A Site Addition Form needs to be completed and can be found here: https://box.rdcrn.org/s/lg665subqlkj15xv725jbmsyslknk0i1

More information on the Site Addition Process can be found in the RDCRN Policies and Procedures document.

Use of the Grants Portal for Pilot Awards and RDCRN Scholar RFAs

The RDCRN Grants tool can be used to collect applications for RDCRN Pilot Awards and RDCRN Scholar awards as well as manage the review and selection process. A full description of the tool can be found here: RDCRN Grants Portal

If there are further questions, please contact your DMCC project manager.