AACI CRI Trial Complexity Form: Tool for Determining Institutional Monitoring Standards
TRIAL COMPLEXITY FACTORS
I. FUNDING SOURCE
Federal funding
Externally Peer Reviewed
Internally Funded (includes industry funded IIT)
II. PHASE (Use current phase of trial and with regard to registration process)
Phase 0 or pilot
Phase I (Toxicity/dose finding)
Phase II (Safety/Efficacy)
Phase III (Effectiveness compared to recognized standard)
Phase IV (post market trials)
III. IND and/or IDE *
IND/IDE (sponsor is your institution or PI)
IND/IDE (sponsor is not your institution or PI)
IND/IDE Exempt
IV. US TRIAL SITES (External to your own site. Add 1pt for each site)
External sites = __________
V. INTERNATIONAL TRIAL SITES (Add 1 pt. for each country)
Country(s) = __________
VI. DRUG ADMINSTRATION
PO or SQ (to be administered by the subject at home)
IV or IM or SQ or other route to be administered by the clinical staff
VII. MODALITY (add 1 pt. for ea. modality of treatment)
# of modality(s) = ________
VIII. AGENT/ Device/Treatment/placebo
Device
Bone Marrow Transplant
Gene transfer or viral vector
Radio-labeled products
Chemotherapy (oral)
Chemotherapy (infusion)
Stem cell transplant
Biotherapy
Standard radiation
Nonstandard radiation
IX. AGENT MANUFACTURING
Cancer Center
X. TISSUE OR BLOOD
Simple or Single sample, (e.g., pre/post drug, pre-study, FU visit)
Multiple and /or complex (e.g., liver biopsy, multiple timed PKs)
Imaging
Other (e.g. ultrasound guided biopsy)
XI. ACCRUAL
Trial accrual to be completed <12 months or site will enroll significant number of subjects, e.g., >10
XII. Investigative Research Personnel Experience
PI experience 0 – 2 years
Staff experience 0 – 1 year
TOTAL
Monitoring Levels
Low
Moderate
High Risk
SCORING OF RISK
Total Ranges
0 to 15 Points
16 to 29 Points
> 30 Points
FORM INSTRUCTIONS: 1.) Assess Trial Complexity Factors (I – XII) completing the Trial Complexity Form (TCF) for each selected interventional
investigator initiated trial. 2.) Each complexity factor is assigned a value 1-3 with a score of 3 being the highest.
*IND or IDE institutionally held studies receive an automatic value of 10. This is the only Complexity Factor exceeding the 1-3 scoring
AACI CRI Trial Complexity Form: Tool for Determining Institutional Monitoring Standards
FORM INSTRUCTIONS: 1.) Assess Trial Complexity Factors (I – XII) completing the Trial Complexity Form (TCF) for each selected interventional
investigator initiated trial. 2.) Each complexity factor is assigned a value 1-3 with a score of 3 being the highest.
*IND or IDE institutionally held studies receive an automatic value of 10. This is the only Complexity Factor exceeding the 1-3 scoring