Frequently asked questions

• User MUST login to ClinicalStudyDataRequest.com
• Click My Dashboard link
• Click your Request Reference Name under the Submitted tab
• Click Conversations tab.
• Click the + symbol to add a message to the Data Sharing team

• How do I Create an account?
  • Click Login/create account in the site header and then click "Create Account" from the drop-down menu. Fill out the form and then click "Create"
  • A follow-up email will be delivered to you with next steps to Validate your account.
  • If the Account Validation email is not received, please check your spam or junk folders or contact site support for assistance.
• How do I Manage my account?
  • After you login, click on your name in the site header and then select "edit profile" from the drop down menu. Update the information on the form and then click "update" at the bottom of the form.
• How do I reset my account password (forgotten password)?
  • At the login page click "forgot password and then follow the instructions.
• How do I request or delete my Personal Identifiable Information (PII)?

  • Should you request a copy of the personally identifiable information we collect about you or wish to have us delete the PII, please contact us at support@clinicalstudydatarequest.com

    Note that if you currently have an Research Proposal or Enquiry under consideration, deleting your PII could directly impact our ability to process those requests.

    Once a data agreement is signed and the research has begun, the lead researcher’s name and Affiliated Institution will appear on the Metrics Page of this site.

• How do I ask questions about the site functionality?
  • Please contact site support for all queries about site functionality. Any queries/questions about the studies listed or not listed should be redirected to specific Sponsor(s).

• How do I submit an enquiry?
  • Click Browse all Studies link from the home page and click the link to submit a enquiry to request documents and/or studies not listed on the site.
• How do I submit a Research Proposal?
  • Search for studies listed on the site by using the keyword search on the home page or click to Browse all Studies and use available filters to narrow down your search.
• How can I request datasets and/or studies not listed on site?
  • For studies not listed, please use the link on the Search Results page to enquire. Sponsor(s) selection is mandatory to direct your questions to a specific Sponsor(s).
• How can I submit questions, request clarifications about my enquiries or Research Proposals?
  • Go to My Dashboard link after logging in the site, click on the Reference Name of the Request you want to ask questions about. Clicking the link opens up the form in read-only mode. Click the Conversation tab and submit your questions.
• How do I upload attachments?
  • To upload documents, please login and click on My Dashboard link in the site header. Click on the Research Proposal/Enquiries Reference Name. Clicking the Reference Name opens up the submission form in read-only mode. Navigate to Attachments" tab and upload any pertinent document.
• Where do I find a description of statuses for Enquiries, Questions and Research Proposals?
  • For a description of statuses assigned to your enquiry or Research Proposal please refer to Review of Requests.

• ☐   The research proposal summary is written in plain English and describes the objectives and the benefits for patients without technical language and medical jargon.
• ☐   The statistical analysis plan provides a sufficient description of the statistical methods that will be used.
• ☐   The publication plan is included.
• ☐   A qualified researcher with expertise in the proposed statistical analyses is part of the research team.
• ☐   All researchers (up to five per research project) that will need access to the data are listed in the research proposal.
• ☐   Downloadable Checklist

• How to ask questions about studies listed on the website
  • Go to search results page and click the "+" symbol to add studies to your Selected Studies List. After adding studies to the list of studies page, click the "Ask Questions about the selected Studies" button. Clicking the button will open up the questions form. Fill out the form and click Submit.

• When can I access the data?
  • Following execution of the DSA, all parties signing, a research area is created in the secure data access system. Each Sponsor will upload their anonymised data and supporting documentation to the secure data access system.
• Can I export data from the secure data access system?
  • There are controls in place to prevent the data and supporting documentation provided by a Sponsor from being exported.
• What tools are available in the secure data access system?
  • The following pre-installed tools are made available for conducting your research; SAS, "R" and Plink.

• User MUST login to ClinicalStudyDataRequest.com
• Click My Dashboard link
• Click your Request Reference Name under the Submitted tab
• Click the Attachments tab to upload a file

You may need to delegate the communication to another team member. In order to include a delegate, please follow the directions below.

If the delegate does not have an existing account on the site, first ask them to create a new account on https://ClinicalStudyDataRequest.com.

• User MUST login to ClinicalStudyDataRequest.com
• Click My Dashboard link
• Click your Request Reference Name under Submitted tab
• Click Conversations tab
• Click the + symbol to add a message to the Data Sharing team requesting to add a Delegate to this request
  • Provide delegate name and email address associated to their account
• After Delegate has been added to your request:
  • Delegate can find your request on their Dashboard after login
  • Both you and the delegate will be notified of any communication via Conversations functionality
  • Delegate will receive all conversation and attachment added notifications from the Data Sharing team