Research Affairs: Researcher's Alert - March 21, 2018

ClinicalTrials.gov studies reassigned effective April 1, 2018

Jerri McIlhagga — Wed, 21 Mar 2018 14:33:24 -0700

Effective April 1, 2018, the registration and results submission for ClinicalTrials.gov studies has been reassigned to the following departments:

PIs requiring assistance in registering cancer-related studies should contact Tami Terry at the Cancer Center: (909) 558-7117 Extension: 87117

PIs requiring assistance in registering non-cancer related studies should contact the Clinical Trials Center at: (909) 558-5830 Extension: 55830

Prior to April 1, 2018, PIs for all types of studies may still contact Jerri McIlhagga for assistance at:

(909) 558-9408 Extension: 49408 Email: jlmcilhagga@llu.edu

Revised IRB Forms

Amy Casey — Wed, 21 Mar 2018 14:40:51 -0700

The IRB forms below have been revised. Since forms and guidance may be updated at any time to reflect new regulations and IRB accreditation, be sure to download the latest versions as needed from the IRB Toolkit for Investigators to avoid delays in the approval process. Contact us at x44531 or email IRB@llu.edu if you have any comments/feedback.

- Archival/Retrospective Data Application Form

- Waiver of Consent/HIPAA Authorization

REMINDER of COI for IRB Process

Amy Casey — Wed, 21 Mar 2018 14:43:56 -0700

Conflict of Interest disclosure and training must be completed for all research personnel responsible for the design, conduct or reporting of a study prior to the study being reviewed, per federal requirements. For full board review this means a study will only be assigned to the IRB agenda once all COI requirements are met.

Are original signatures always required on forms submitted through Research Affairs?

Linda Halstead — Wed, 21 Mar 2018 14:55:30 -0700

Signatures of Principal Investigators and their Department Chairs are frequently required on submissions to Research Affairs (IRB, IACUC, grants, etc.). The purpose of such signatures is to assure that key responsible persons are personally approving the content of important documentation. Research Affairs, consistent with institutional policy, in lieu of original signatures, will accept the following:

digital signatures created through DocuSign, Adobe, or similar software
communications or documents submitted directly from the authorizing individual’s campus email
signature affixed using stamps or cut-n-paste images with initial and date of person acting on behalf of signatory
authenticated logins in Research Affairs electronic systems

Note: If the signatory person or the individual acting on his/her behalf is NOT an LLUH employee, the signature must be accompanied by a copy of that individual’s valid Driver’s License