Advancing today’s discoveries to improve health for all.

Study Start-up

Study Start-up

Support in the beginning stages of your study.

Data Collection Tools/Databases

There are three databases used regularly at The Ohio State University. The ones that are currently FDA 21 CFR part 11 compliant are designated with an asterisk. This means they are able to meet the FDA standards which is necessary for implementation of trials involving an IND/IDE.

  • REDCap is an open source tool that provides study staff with tools to manage projects, participants and research data. The CTSI can assist researchers to develop studies utilizing REDCap.
  • Oncore Database* is available only to staff within the College of Medicine 
  • StudyTrax* permits the user to build data collection forms as web pages. StudyTrax comes with built-in report and dataset generators; data can be exported to SAS or SPSS formats, Excel or Word. StudyTrax explicitly supports multicenter trials with an option to define sites. 

The CTSI can help ensure you have created a good clinical database and how to capture items to be easily accessed by the statistician later. Reach out to CTSI-info@osumc.edu for a free consultation.

REDCap Boilerplate Language for the IRB or Grant Application

This is a template that can be used for the IRB Application when utilizing REDCap for a registry protocol.

Access REDCap Boilerplate Language

Consent Document Preparation

Support for drafting, revising and finalizing consent documents

In addition to providing consent process and document support, a library of template language for various study procedures and their respective risks has been created for access and use by the research community. These may be accessed below:

Regulatory Documents Master Trial Folder

Essential documents are commonly referred to as regulatory documents. International Conference on Harmonization (ICH) Good Clinical Practices (GCP) guidance defines essential documents as “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced. These documents serve to demonstrate the compliance of the investigator, sponsor and monitor with the standards of Good Clinical Practice and with all applicable regulatory requirements.”

A trial master file should be established at the beginning of any research study and maintained throughout the study. This file aids in the management of the study and is often a piece that is audited by study monitors and FDA officials. Unless otherwise noted, copies of all documents should be placed in the master file at the site and with the study sponsor or Contract Research Organization (CRO).

This Master Clinical File Guidance template outlines the required documents according to ICH E6 Guidance for Industry: Good Clinical Practice (GCP) (PDF). At the industry level and the site level.

Fiscal Management

After an award has been accepted and/or a contract signed by the Office of Sponsored Programs (OSP) on behalf of the Principal Investigator (PI), the Office of Grants and Contracts (OGC) will establish and award number(s) when the following items are in place:

  • The Ohio State Financial Conflict of Interest Screening/Disclosure Form (eCOI) (required at proposal stage) completed by the PI and approved by the Office of Research Compliance
  • Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) approval (if applicable)
  • Fully signed contract or award on file at OSP
  • All effort reports have been certified or are in the process of being corrected for all of the investigator’s projects

Some awards may also require additional agreements be in place, such as technology commercialization plans, confidential disclosure agreements or conflict of interest management plans. Conflict of interest management plans are handled by the ORC.

The OSP award number is a unique number that starts with AWD–six digits (example: AWD-123456). The award number is where study documents and study details are saved on the project in the PI Portal. The award number is typically used by OSP employees when they communicate with PIs. It is also one of the identifiers that can be used to obtain project-related financial information from the OSP electronic research administration project management tool (PI Portal). The award number is NOT what a PI or study team would use to purchase services on.  

After the award has been received and the project is set up. The Sponsored Program Officer (SPO) will create separate grant numbers associated with the project to allow one to spend on. They will be listed with GR and six digits (example: GR123456). The reason behind making a separate grant number is to easily track spending restrictions on the funds received. Awards will have at least one grant number assigned but could have several grant numbers assigned.   

Examples of why you would have additional grant numbers on a project:

  • You have a subaward on your project. There will be a separate grant number associated for your subaward and one for spending that will occur at Ohio State. The budget will be split on the grant numbers as it was defined in the grant submission.
  • The sponsor limits salary spending on the notice of award to $100,000 and the remaining funds are to be used for clinical tasks. The SPO will set up one grant number for the salaries and one for the remaining charges.
  • The PI should separate clinical fees for the trial from the rest of the expenditures to stay on budget. The PI can request that the SPO creates two grant numbers.

Note: Even if the project comes from industry it is still listed as a grant number in the PI Portal and Workday system.  

Investigators and their staff are responsible for reviewing all project costs to ensure they are reasonable and appropriately assigned to the project, must approve purchases greater than $3,000 and must approve payments to sub awardees. The OSP is responsible for completing all purchase transactions, issuing payments, processing travel reimbursements and human subject payments and billing sponsors.

The following items are best covered on the Office of Research Page- Award Management.

The Sponsored Program Officer and Grants Manager is the best resource to check on how to complete the following and any questions on your project.  

Drug Supply Management and Accountability

The record keeping associated with the receipt, storage and dispensation of an investigational product is known as study drug accountability. While the study sponsor is responsible for packaging and distributing the product to the study sites, it is the responsibility of the site to maintain adequate records of the products’ handling and dispensation.

Often sponsors will provide tools such as tracking logs to assist in the maintenance of such records. However, if no tools are offered by the sponsor, the site should plan to develop their own tracking method. For all hospital-based drug studies, Investigational Drug Services is responsible for managing the research study drug supply and drug accountability records.