Clinical study initiation

Welcome to our Clinical Study Initiation page. Here, we aim to streamline the process of starting a clinical study by collecting essential information about your proposed research. The form below is designed to gather the details necessary for evaluating the feasibility and potentially supporting your study. Please provide as much information as possible about your study's objectives, methodology, participant criteria, and other pertinent details. This information will help us understand and assist in connecting you with the correct healthcare specialists at Stormont Vail.

Please email Ramasamy Sakthivel if a confidential agreement is required for this research projects.

If you see this don't fill out this input box.

Study title*

K-State IRB approval number

PI name*

PI title*

PI department*

PI phone number

PI email address*

Co-Principal Investigator(s)

Funding/sponsorship information

Study overview*

Conditions or focus of study*

Primary outcome measure*

Secondary outcome measure(s)*

Is this a pilot study? (A small-scale test of the methods and procedures to assess the feasibility/acceptability of an approach to be used in a larger scale study.)

Yes

Please identify the study type

Interventional - participants assigned to intervention(s) based on a protocol

Observational - participants not assigned to intervention(s) based on a protocol; typically in context of routine care

*If Other

Research methodologies*

Resources*

Does this study evaluate a disease that would qualify as a Rare Disease or Condition as defined by the NIH?

Yes

Will drugs, biologics, or devices be used in the study?

Yes

If YES, please indicate the name of the drug or biologic

Is the drug/biologic/device FDA approved or exempt?

Yes

N/A

If NO, please provide the following:

Projected start date*

Expected duration (in years) of study from initial enrollment to completion of last subject

Anticipated total number of participants to be enrolled*

Are study procedures part of a regular medical visit?

Yes

Both

If YES, please provide:

If NO, please provide:

If the KSU-SV Research Center in the Stormont Vail Manhattan Campus is required, please provide:

Participant description

Sex

All

Female

Male

Age limits

Inclusion criteria

Exclusion criteria

Please indicate if Stormont Vail participant recruitment services are requested

Yes

If YES, select the potential methods by which this study will identify possible participants

*If Other

Please indicate if Stormont Vail Medical Team services are requested

Yes

*If Other

Access to electronic health records

Yes

If YES, have you previously used SV electronic health records for research?

Yes

N/A

Please indicate which portions of the medical record you will need to access to complete research

For what time period do you need access?

Clinical Study Initiation Form