What is CRADAbase?

CRADAbase shared repository for crowd-sourced information about in-progress clinical trials purpose-built for the VA-NPCs.

CRADAbase's purpose is:

1. To help NPCs working on the same trial connect with one another
2. To help the NPC community as a whole track approval timelines for crucial study documents like CRADAs.

CRADAbase allows you to enter and update new clinical trial, CRADA, and CDA records for your NPC and search the records created by other NPCs. CRADAbase functions similarly to the now-defunct eCRADA registry, the precursor to the current SOPHIA database used by VA's Technology Transfer Program (TTP) to track CRADAs. Since CRADAs and trials are only entered into SOPHIA once they are executed, NPCs cannot use SOPHIA to coordinate with one another on CRADAs and trials that are still being approved. That's where CRADAbase comes in.

How do I use CRADAbase?

Create an account, choose your NPC, and start creating and searching trials!

Quick links

Jump to how to creating an account and choose which NPC you belong to.

Jump to searching the database.

Jump to entering a new clinical trial record.

Create an account.

In the top right, click Log in.

Where you see New to this site?, click Sign up. Your login credentials from the old NAVREF site will not work here.

Enter a username and password. When you click submit, you will receive a message that your account is awaiting approval. I will be checking the access requests a few time a day and will approve your access. At this point, you will receive an email that you can log in to view CRADAbase.

Choose your NPC.

Click your account name in the top right and select Account Settings form the resulting dropdown.

Scroll down to the section My Organizations. 

Select your NPC from the dropdown and select Submit. You should see your NPC listed under organizations and your role shown as Member. In the future, approval will be needed in order for people to associate their accounts with NPCs, but for testing I've disabled the approval step.

Search for a trial

You can do this by entering keywords for a study title/name, selecting a sponsor, entering a protocol number, NCT number, or OGCLaws number. In the future, trials will also be tagged and searchable by medical specialty/disease area, but this functionality has not been implemented yet.

Click on a trial to see more information. Depending on the data available for each trial, you will be able to see the following information:

If the trial has an NCT (national clinical trial) number, you will be able to see some basic information about the dates and type of study.

If any NPCs have indicated that they are participating in the trial, you will be able to see them (click on their name to be taken to their directory page), along with records of any documents that they have recorded (currently, only CRADAs and CDAs are implemented). The documents themselves are not available, but NPCs can record when they were received from the sponsor, when they were submitted to OGC and when they were fully executed.

You can add your NPC to an existing trial by clicking Add my NPC to this Record at the bottom of the page.

Create a new clinical trial.

Return to the CRADAbase search page by clicking the browser back button or the Back to CRADAbase button on the webpage. Click Add a New Trial, which is below the filter options. The new trial workflow looks like this:

Enter the NCT number or protocol number of the trial, if you have it, then click ClinicalTrials.gov Lookup. If the NCT number or protocol number you entered matches a record on ClinicalTrials.gov, the rest of the form will automatically populate with info available from ClinicalTrials.gov. Note that in this case, you will need to confirm the match for the sponsor (and CRO if applicable).

If you don't have an NCT or protocol number, you can enter the trial information manually. The Sponsor and CRO fields allow you to search from existing organizations in the database. Click on the correct option to select it. If the organization you want does not show up, click Add Organization to add a new organization. The name will be taken from what you have entered in the search bar.

Once the information is correct, click Save at the bottom of the page.

You will be taken to the new page that has just been created for that trial, but your NPC is not added to the trial automatically. To add your NPC, click Add my NPC to this Record at the bottom of the page.

Add study-related documents and track the timeline of approval actions.

When your NPC is added to a clinical trial record under NPC Sites, you will see an option to Edit Records next to your NPC's name. Click this option to add and edit study documents.

On the Edit Docs Associated with Trial page, you will see the option to add a document. The Document Type field is required; the GCL and attorney fields are optional. Once you have selected a document type, click Add Document on the righthand side.

Now that the document has been added, you can edit its properties and record the dates of actions in its approval process. To add the dates of approval actions, click the grey circle next to each action. The circle will turn into a green check and show a date next to the action. This defaults to today's date, but you can click the date to edit it. Not all dates in the timeline need to be selected.

Information on the page saves automatically. When you are done editing, you can click Back to Trial in the top right to see the information you entered reflected on the trial page.