Study Staff Signature and Responsibilities Log

Investigator: ______Site: ______Effective Date: ______

Protocol Title and No.:______

Name – Print (First, Last) / Title / Signature / Initials / Research Responsibilities / Dates of Responsibility
Please see Legend* on p. 2 / From / To

I have reviewed this document, and agree to the designated party(ies) assigned to each responsibility. I understand that this document does not remove my responsibilities as Investigator, as defined in the Investigator Agreement and applicable regulatory documents.

______

Principal Investigator’s Printed Name Principal Investigator’s Signature and Date

*Legend

Use Legend to complete the “Research Responsibilities” column. Please enter the letter(s) in column that corresponds to the responsibilities of the individual. For responsibilities that are not already indicated in the legend, please add them in the empty spaces provided below.

A.  Obtains consent

B.  Completion of CRFs and Data Entry

C.  Correction of CRFs

D.  Review of CRFs (must be investigator or sub-investigator)

E.  Review and resolve Data Clarification requests

F.  Communication with Ethics Committee

G.  Physical exam

H.  Study Drug Accountability: Dispensing of medication and Drug Compliance assessments per Investigational Drug Brochure

I.  Regulatory submission: Submit the protocol, Informed Consent and Patient Authorization Form, and other documents that are required by the IRB for approval. Inform the IRB of amendments, as applicable

J.  Provide guidance and training of sub-investigators and other study site personnel on proper conduct of the trial

K.  Complete and fax screening log to ACRIN, as applicable

L.  Collect, document and report adverse and serious adverse events to ACRIN and IRB, as applicable

This log should include the investigators, sub-investigators, study coordinator and all other clinic staff who routinely see study subjects and who have specific data collection/interpretation responsibilities. This log should also include contracted specialists performing protocol required examinations. New or replacement staff should be added as appropriate.

Sponsor/Investigator

Version Date: fnl 12-11-2008