Protocol Short Title
* must provide value
(i.e: the acronym or shortened moniker for the study)
Does the protocol involve human subjects?
* must provide value
Yes No
For information about human subject research versus non-human subjects research, please consult: https://research.iu.edu/compliance/human-subjects/submissions/new-studies.html
Is there an investigative product?
* must provide value
Yes No
(e.g: drug or device)
What type of investigative product?
* must provide value
Drug Device
Or enter "n/a" if there is no IND # or it is not available yet
Or enter "n/a" if there is no INE # or it is not available yet
How will the study be funded?
* must provide value
Please describe the other funding sources:
* must provide value
What is the study design?
Interventional Observational Other
Please describe the study design:
* must provide value
If applicable, what Phase is the study?
N/A or Unknown Phase I Phase II Phase III Phase IV
Will some or all of the study team will be blinded?
The entire study team will be blinded A portion of the study team will be blinded The study is not blinded or N/A
Please explain the blinding plan
Person submitting this form:
* must provide value
Email of person completing this form:
* must provide value
How did the study team learn about this study?
Where will the study be conducted?
* must provide value
IU Health Arnett Hospital IU Health Ball Hospital IU Health Bloomington Hospital IU Health Methodist Hospital IU Health North Hospital IU Health Saxony Hospital IU Health University Hospital IU Health West Hospital Eskenazi Hospital VA Hospital Other
If the study will be multi-site, please indicate the lead site.
Has a PI been identified for this study?
* must provide value
Yes No
What is the name of the investigator?
* must provide value
Please include first and last name.
If applicable, how many active studies is the PI currently conducting?
If known, include how many studies they may also be serving as co or sub investigator.
Are there any concerns about PI availability, or providing adequate oversight?
Yes No
Please describe the known challenges, as well as how the team plans to address them:
If the study involves blinding, please include this in your considerations
Will there be sub-investigators on the study?
* must provide value
Yes No
This excludes multi-site studies, which will be addressed further in this checklist.
Please list the sub-investigators
* must provide value
Please include first and last name, as well as relevant credentials (e.g: MD, DO, RN, PhD, etc...)
Has the study team identified sufficient coordinators and support staff to conduct the protocol?
* must provide value
Yes No
Please describe the plan to acquire sufficient resources, or please clearly describe the assistance needed to conduct the protocol.
* must provide value
Will the study use the IU IRB or a Central IRB?
* must provide value
IU IRB Central IRB
If known, which IRB will the study use?
Will this be a multi-site study within the IU Health enterprise?
* must provide value
Yes No
If the study may add additional site in the future, please selected "yes."
This study is likely to be considered a "Scenario 1" study. Please review the Statewide Workflow for additional feasibility considerations.
This study is likely to be considered a "Scenario 2" study. Please review the Statewide Workflow for additional feasibility considerations.
Please select all sites where the study might be conducted:
* must provide value
Please do not include the lead site again when answering.
Who will serve as the satellite investigator for IU Health Arnett?
Who will serve as the satellite investigator for IU Health Ball Memorial Hospital?
Who will serve as the satellite investigator for IU Health Bloomington Hospital?
Who will serve as the satellite investigator for IU Health Methodist Hospital?
Who will serve as the satellite investigator for IU Health North Hospital?
Who will serve as the satellite investigator for IU Health Saxony Hospital?
Who will serve as the satellite investigator for IU Health University Hospital?
Who will serve as the satellite investigator for IU Health West Hospital?
Who will serve as the satellite investigator for Eskenazi Hospital?
Who will serve as the satellite investigator for the VA Hospital?
Please describe which "other" site(s):
Who will serve as the satellite investigator(s) for the other site(s)?
Are there any logistical concerns for this study?
* must provide value
Yes No
If there are concerns about logistics for satellite sites, please select "no."
Please describe the known or anticipated logistical problems conducting the study:
(i.e: What are the currently-anticipated challenges at the participating site(s)?)
Are there any concerns about the scientific merit of the study?
* must provide value
Yes No
Please describe the concerns about the study's scientific merit or worth:
Is Risk-Based Monitoring required above and beyond normal monitoring requirements?
Yes No
What is the target study patient population?
* must provide value
(i.e: women with triple negative breast cancer, patients with a history of asthma, etc...)
Any concerning inclusion criteria that needs to be addressed?
* must provide value
Any concerning exclusion criteria that needs to be addressed?
* must provide value
If the study will be looking at specific ICD 10 or CPT codes, please list them:
Is the risk level, or risk/benefit ratio, acceptable?
Yes No
If the risk/benefit ratio may pose a challenge to recruitment, select "no"
What are the known barriers and challenges to enrollment?
(i.e: does the patient population include rare diseases, vulnerable subjects, difficult to consent subjects, etc?)
Will the subject (or an LAR) be consenting to participate in the study, or will the study apply for a waiver of consent?
* must provide value
N/A Consenting Waiver of Consent
How many months will the study be open to enrollment?
* must provide value
How many total subjects will be recruited at your main site?
* must provide value
Please state as a number
Is ______ months realistic to recruit ______ subjects?
Yes No
Based on the length of enrollment and anticipated recruitment, it is expected that this many subjects need to be enrolled each month:
View equation
The calculated recruitment rate is ______ per month. Does that seem like a realistic and feasible rate?
Yes No
How many subjects is each satellite site expected to enroll?
* must provide value
What is the study team's plan to address the challenges of recruitment?
* must provide value
Are there any competing studies that may affect the recruitment rate?
N/A Yes No
If known, please list the competing studies, and how the study team plans to address the recruitment challenge:
* must provide value
Will the study have labs?
* must provide value
Central labs location:
* must provide value
Please provide name and address of Central Lab
Are there required biospecimens or PK samples?
* must provide value
N/A Yes No
Will ORI/Imaging Services be required?
* must provide value
N/A Yes No
What type of imaging services and how frequently?
* must provide value
Will the Screening Visit involve more than one in-person office visit by the patient?
* must provide value
Yes No
Most screening visits are one office appointment for subjects
How many in-person office visits will the subject need to complete for their Screening Visit?
Total number of study visits per subject:
Average number of visits if subject completed study according to protocol
Average length of study visits in hours:
This is for estimating labor and reserving research space. Please provide an approximation in hours.
Are there invasive procedures (other than blood draws)?
* must provide value
N/A Yes No
Please briefly describe the invasive procedures:
* must provide value
Can all labs and study procedures be completed within the IU Health system?
Yes
No
Uncertain
Please provide more details on what labs or procedures that study team might not be able to perform as per protocol requirements:
Will the study's procedures require any external specialists/resources/departments?
* must provide value
N/A Yes No
Answer "yes" if it would require a business agreement, additional invoicing, or similar arrangement.
Please describe what external resources are needed:
* must provide value
Is any special equipment required?
* must provide value
N/A Yes No
If the equipment would need to be purchased, or usage of the equipment reserved, please answer "yes."
Please describe the special equipment, and how the study plans to acquire the equipment:
* must provide value
If the study is multi-site, please include how the satellites will gain access to the special equipment.
Will emergency rescue equipment be necessary?
* must provide value
N/A Yes No
Please describe what emergency rescue equipment will be required:
Is the study challenging for subjects to complete? Or, does the study team anticipate subjects having difficulty with complying with the study requirements?
* must provide value
N/A Yes No
(i.e: are there difficult to follow procedures at home, frequent study visits with significant travel, painful/difficult study procedures, etc...?)
Please explain what patients may find challenging and why:
* must provide value
Is special storage needed for the Study ______ ?
* must provide value
Yes No
Please briefly describe how the Study ______ needs to be maintained:
* must provide value
Will the use of IDS or Pharmacy be required?
* must provide value
Yes No
Will the study team be required to prepare or manipulate any drugs?
* must provide value
Yes No
Please briefly describe the drug preparation:
* must provide value
Is the Study ______ dispensing/accountability complicated?
* must provide value
Yes No
Will electronic screen tools be required?
* must provide value
N/A Yes No
Will the study use subject diaries?
* must provide value
N/A Yes No
Do the subject diaries need to be transcribed?
* must provide value
Yes No
Are Order Sets required?
* must provide value
N/A Yes No
Submit
Save & Return Later