Changes to CHR Forms in iRIS

April 11, 2014

The CHR has published minor changes to the Study Application, Initial Review Submission Packet Form, the Modification Form, the Continuing Review Form, the Protocol Violation/Incident Reporting Form and the Adverse Event Reporting Form. Changes by form and section are:

Study Application Form

“CTSI Screening Questions” Section

Q1: Use of CRS services or centers.

  • List of CRS centers has been added
  • Selecting ‘Yes” to use of CRS services or centers no longer branches to CRS Application Form section (form now submitted online directly to the CRS email box)

Initial Review Submission Packet Form

“VA Forms” Section

Q2 and Q3: Added reminder of what needs to be included in applications involving the VA.

Modification Form

“Modification Form” Section

Q6: Type of modification – Added options for

  • Single subject exception
  • Modification to follow subject or subject’s partner who became pregnant on study
  • Adding new funding sources

Q7: Combined the proposed modifications and rationale questions into one

Q8: New question screening for VA involvement

Q9: New question screening for adding use of CRS centers or services for the first time

Q10: Changes to financial interests question moved from “Updated Financial Disclosure” section

“Updated Financial Disclosure” Section - eliminated

Continuing Review Form

“Continuing Review Form” Section

Q9: Changes to financial interests question moved from “Updated Financial Disclosure” section

“Updated Financial Disclosure” Section – eliminated

“New Modifications” Section

Q6: Type of modification – Added options for

  • Single subject exception
  • Modification to follow subject or subject’s partner who became pregnant on study
  • Adding new funding sources

Q7: New question screening for VA involvement

Q8: New question screening for adding use of CRS centers or services for the first time

Protocol Violation/Incident Report Form

“Protocol Violation/Incident Report Form” Section

  • Added instruction not to include any PHI in the form or attachments
  • Made minor changes to wording, question order and data value captions to be consistent with other forms.

Adverse Event Reporting Form

“Adverse Event Reporting Form” Section

  • Added instruction not to include any PHI in the form or attachments
  • Made minor changes to wording, question order and data value captions to be consistent with other forms.