Clinical Research Trial - LOI
Title (Please provide full protocol or project title)
Is this a Final version of the protocol? Yes No (If no, please submit the Final protocol)
Does this trial involve gene therapy? Yes No
Is this a UAB investigator-initiated trial? Yes No
If yes, have the statistician(s) involved in the development of the trial reviewed and approved the final statistical design of the protocol? Yes No
Statistician (print name):
Signature:
If this is a UAB investigator-initiated trial, has monitoring for the site(s) been included in the budget? Yes No
Will this protocol include outside sites? Yes No
If yes, please list the site(s):
If this is an industry-sponsored, externally peer-reviewed or cooperative group/national trial, has the sponsor approved UAB as a site for this trial? Yes No
Has the protocol been reviewed by an NCI accredited academic institution? Yes No
Life cycle of the protocol:
How long has this study been open for enrollment?
How many institutions are participating?
What is the current enrollment?
Phase: Pilot/Feasibility Phase I Phase I/II Phase II Phase II/IIIPhase III
Other:N/A
If this is a phase I or I/II protocol, has it been discussed with phase I group? Yes No
Conclusion of the discussion with phase I or reason for not discussing it:
UAB PI:
UAB Co-Investigators:
Sponsor:
Investigational agent: Yes No
If yes, IND # IND Sponsor
If yes, Mechanism of action:
Does this protocol require a consent form?Yes No
Site: UAB UAB Clinical Trials Network(CTN) If yes for CTN, please provide the name of Network Site:(GCS; Medical Center of Central Georgia; etc.) Other:
Study population:
Objectives:
Key Eligibility criteria (in brief):
Treatment/study plan:
Laboratory Correlative Studies: Yes No
Includes Specimen Banking: Yes No
Adjuvant: Yes No
Does the protocol represent translational research? Yes No
Annual accrual target(upper/lower):(/)Total accrual target upper/lower: (/)
Estimated years of enrollment in the UAB:
Have the accrual numbers been agreed upon with the sponsor? Yes No
(For Cancer Control & Population Science studies please attach accrual table for race, gender & ethnicity)
Will protocol utilize: Clinical Studies Unit CRU (GCRC) TKC Infusion Rx
Phase I Clinic Other:
Is the protocol:Single Site Multi-institutional
Data Safety & Monitoring Plan: UAB plan appropriate Modified plan attached
Does the protocol utilize standard of care radiation exposure? (If no, it will it require review by the Radiation Safety Committee) Yes No NA
Was protocol written by UAB faculty? Yes (If yes, please complete the section below) No
Did UAB faculty contribute to the protocol development? Yes No
If yes, UAB Collaborator Collaborator outside UAB
Has the protocol been externally reviewed? Yes No
If yes, NCI/NIH Pharmaceutical sponsor Other (Please specify):
(For Cancer Control & Population Science studies, please attach protocol, or grant description, summary statements, & Description of any modification - if applicable)
Funding Mechanism:
NCI/NIH (Grant # ) Pharmaceutical Sponsor Other
Fully fundedPartially funded Unfunded
What funding is available and amount?
(Investigator needs an amount and/orconfirmation that the company will negotiate)
For GOG protocols, please provide the point system:
Is funding provided for CSU nursing / data management? YesNo
If yes, amount and source
Nursing/Data Management Clinical Studies Unit Other
Program Category: (Please assign to the most applicable category):
Tumor Immunology
Virology
Experimental Therapeutics
Cancer Cell Biology
Chemoprevention
Neuro-Oncology
Cancer Control & Population Science
Nature of Protocol:
Treatment Prevention
Diagnostic Correlative
Screening Supportive Care
Please return this form via email to and
To be completed by the Disease Working Group
Protocol title or key words:
Date of formal working group review:
Number of physicians attending this meeting:
Note: Since ad hoc reviews are discouraged, it is suggested that meetings be scheduled frequently to prevent the need for emergency or ad hoc meetings. A review and signoff represented by the working group chairman is not allowed.
Is there interest among the members of this working group in the conduct of this trial at UAB? Yes No
Will there be patients to support the accrual requirements
for this protocol? Yes No
Does this protocol compete with other active or pending(in development, new, DWG approved CTOC approved, or under regulatory/budget processing) protocols? Yes No If yes, please list them and justify why this protocol should be activated.
Please prioritize the top 3-5 protocols in this disease site that are active or pending activation. (Pending IRB approval, budget, contract, etc.)
; ; ; ;
In order to provide appropriate regulatory and budgetary priority, please provide the level of working group scientific interest using the scale below. This score will reflect the level of priority as an individual study and also where it ranks in relation to all other trials for this disease site – active and pending: (Ranking all trials high priority will not prioritize any protocols)
1 - (0 - 25%) Low (e.g., multi-institutional trial with low potential for authorship)
2 – (25% - 50%) Low Mid-range
3 – (50% - 75%) High Mid-range
4 – (75% - 100%) High (Often includes investigator-initiated trials)
Comment(Not required):
Were there any clinical or safety concerns raised with the review of this protocol Yes No
If yes, please elaborate:
Approved Disapproved
Reviewer’s Signature: Date:
Please return this form via email to
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Clinical Trial LOI
(Revised 09/01/2016)