AHC Department of Research

Protocol Review Committee

Study Feasibility Assessment (SUP-500.1M)

I. STUDY INFORMATION
A. Study Title:
B. Protocol #: / C. SID# To be assigned by Dept of Research:
D. Sponsor: / E. Non-AHC Site: / EDW/ELM Other ______
F. Site(s): / CMC LGH IMMC ACH-OL ACH-PR BROM AMG ______
GSAM GSHP EUR TRIN SHERM COND SSH Other ______
G. Type of Research/ Funding: / 1. Industry-Sponsored 2. Cooperative Group ______
3. Investigator-Initiated a. Funded ______b. Unfunded
4. Grant Funded a. Specify Funder______b. Primary Awardee c. Sub-awardee
H. Anticipated Start Date: / I. Duration of Study:
II. CONTACT INFORMATION
PI / Title / Pager/ph / Email
AMG/AHC APP Physician Fellow Nurse Pharmacist Resident Other
Sub-I / Title / Pager/ph / Email
Sub-I / Title / Pager/ph / Email
Sub-I / Title / Pager/ph / Email
RC / Title / Pager/ph / Email
Form completed by:
III. STUDY CHARACTERISTICS
A. ResearchType: / 1. Clinical Basic If Clinical, proceed:
2. Expanded Access/Compassionate Use/Emergency Use NOTE: If #2, STOP completing form and contact Director of Research.
3. Interventional/Treatment/Experimental OR Non-interventional/Observational
a.If Interventional select one:
(1) Randomized control trial
(2) Non-randomized
(3) Other
b.If Non-interventional select one from each column:
(1) Registry (5) Retrospective
(2) Survey only (6) Prospective
(3) Chart review/analysis of existing data
(4) Other
B.Intervention
Type: / 1. Agent 2. Device (Skip to #D) 3. Other Please specify:______
4. N/A ; If N/A, skip to skip to #E below.
C. Phase-drug studies only / 1. I 2. II 3. III 4. IV 5. Other ______
D.IND/IDE/HDE: / 1. IND#______2. IDE#______3. HDE#______
4. If there is no IND#/IDE# or HDE#, is there a determination letter from the FDA stating an IND#/IDE# is not required? Yes No If yes, skip to #E.
5. If there is no IND#/IDE# or HDE#, do you plan to use the drug/device exactly as it is approved for use by the FDA (i.e., indication, patient population, route of administration & dosage)? Routine use is not always indicative of FDA approval. Yes No If No, please contact the site Director of Research for assistance.
E. What are the known risks/benefits?
F. Alternative therapies (specify):
IV. ENROLLMENT & RECRUITMENT
A. Enrollment Target (Total/AHC): / B. Rate of Enrollment/Anticipated Accrual:
C. Estimate of Eligible Patient Population at Site:
D. Is the proposed enrollment goal realistic in the enrollment period?
E. Specify Recruitment Plan (If assistance is needed in identifying patient pop’n contact research site):
F. Any challenges noted with recruitment (e.g., biggest inclusion/exclusion barriers; success with similar studies; timing of consent discussion; patient participation and/or compliance):
G. Is there a competing study at the proposed site? Yes No If yes, provide trial name and justification for opening proposed study.
H. Is there interest in conducting this study at another AHC site? Yes No Describe:______
V. STAFFING, TRAINING & RESOURCE UTILIZATION
A. Is study utilizing AHC Department of Research resources (e.g., Coordinator, regulatory, analytics)? Yes No
B. Expertise required:
C. Will coordination with other departments/services be required for study visits or procedures? Yes No
If yes, complete table / Describe impact (e.g., staffing; financially; equipment; specific training required):
Department / Space/Storage / Staffing / Training/
Provided By / Equipment/
Availability / Other
e.g.: Pharmacy, Lab, Hospital Nursing Staff, Patient Care Areas / Drug storage / Pharmacist to mix drug / Rsch will Provide Pharmacy Info. Form/IB / N/A / Temp logs will be collected quarterly
D. On-call staffing: Yes No
E. Will hospitalization outside of conventional care be required as part of the protocol? Yes No
VI. SUBMISSION INSTRUCTIONS
Checklist: / Study summary (1 page) Inclusion/exclusion criteria Full protocol Study schedule Budget
Site / Director of Research / Phone / Email
CMC/SSH/TRIN / Chris Blair / (708) 684-5137 /
ACH-OL/ACH-PR / Denise Angst, PhD, RN / (847) 723-7570 /
IMMC/GSAM/ BROM/EUR / Dana Villines, MA / (773) 296-5013 /
LGH/GSHP/COND/SHERM / Nancy Cipparrone / (847) 723-7391 /
AMG/GSAM Cardiology / Lea Elder, RN, MSN,MBA, CCRC / (630) 873-3403 /
VII. PI ATTESTATION
By signing this Study Feasibility Assessment, I represent that the information is accurate to the best of my knowledge. For studies managed by the Department of Research, I agree to meet with the Research Coordinator and/or other study team members as needed and at least once per month to attend to study administrative requirements, and to be accessible to the study monitor during interval monitoring visits. I represent that the trial will be conducted in compliance with the federal regulations relating to the protection of human subjects and AHC policies, and that all aspects of the trial will be conducted according to the appropriate standards of scientific integrity.
Principal Investigator: / Date:
VIII.FOR DEPARTMENT OF RESEARCH USE ONLY
Date received: / Study ID (SID) assigned:
Date reviewed by PRC:
Comments:

Rev. 2/21/14