Requestor's Information (*Required Fields):

HRC Requested (To be completed by HRC personnel)

Site Requested Select Principal Investigator Co-Investigator Research Nurse Study Coordinator

*Name: First M Last

*Telephone: Fax: (Do not use hyphens)

*E-mail:

Years participating in clinical research:  Select 0-1 1-5 5-10 10+

Study Information:

Protocol #: (If assigned)

Study Title:

*Principal Investigator: (If different from requestor)

*Address:

*Institution: Select PHS MGH BWH NW Spaulding Faulkner McLean North Shore Medical   Department:

Types of studies conducting/working on (check all that apply):

Drug     Device     Genetics     Questionnaire

Medical Records/Database Review     Tissue Repository

Other

Funding Sources (check all that apply):

Industry    NIH     Private/Public Foundation  

Internal Non-Profit Federal State/Local

Other

Initial Study Review Type:

Expedited    Full    

Have you worked with the QI Program in the past? Select yes no

 Requested QI Service: You may sign up for more than one.

Preparatory to Research:

Study Start-up (Includes assistance with CRF development and implementation of Study Mgt. Tools)

Regulatory Binder Consultation

IND/IDE Holder Assistance:

IND/IDE Sponsor-Investigator Certification

IND/IDE Annual Study On-Site Review

IND/IDE Application Review

Audit Prep Assistance:

FDA Audit Prep Pre-Inspection Visit

Sponsor Audit Prep Pre-Inspection Visit

Study Maintenance: Focused QI Reviews:

Informed Consent Process Monitoring

Subject Enrollment (Includes Consent and Eligibility review)

Regulatory Documentation

IRB Documentation

Adverse Event Reporting (Includes source/data verification and adequate reporting of AEs to HRC, FDA, or other)

Drug/Device Accountability

Protocol Compliance: Violation/Deviation reporting (A sample is reviewed for SDV of procedures/time points required per protocol)

CRF Completion (Review a sample for accuracy, completeness, legibility, and corrections)

Other:

QI In-service (Please indicate topic if known):

Other: Site Requested focused review - (e.g. review of specific data point for consistency/trends - e.g. labs or con-meds)

Other: HRC/IRB Requested review - (e.g. requestor can provide details for QI visit or refer to IRB notification/review)

For a complete description of QI Services, please visit the QI Program's Activities & Services Page.