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 Amy Bartlett 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.
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:
- Biopsy - Muscle and Tissue (PDF)
- Cardiology (PDF)
- Central Venous Catheter (PDF)
- CRC Bionutrition Studies (PDF)
- Dentistry (PDF)
- Drug/Device - General (PDF)
- Endocrinology (PDF)
- Exercise Testing (PDF)
- Genetic Testing (PDF)
- Immunology (PDF)
- Missing Data (PDF)
- Nephrology (PDF)
- Neurology (PDF)
- OBGYN - Pregnancy, Pap Smear, etc. (PDF)
- Psychological (PDF)
- Pulmonary, Sleep, Critical Care (PDF)
- Radiology (PDF)
- Sample Storage and Use (PDF)
- Specimen Collection, Vitals, etc. (PDF)
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.
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Goods and services from off-campus vendors are typically purchased electronically by using the university’s financial system (Workday). If a requisition or purchase order is submitted electronically, it must be done so by an individual authorized to enter requisitions or purchase orders on behalf of a project or department. Purchase orders are generated from the information provided on the requisition and are sent to vendors by the procurement department. Upon receiving requisitions, OSP buyers will review projects for available funds, whether the purchase is allowed and reasonable for the project. They will also check to confirm that the request is within the project’s start and end dates and then send the purchase orders to the vendors.
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The procurement card is a convenient method of purchasing small dollar materials and supplies on research projects. The benefit of using the procurement card is the ability to purchase items directly without submitting a requisition form. The charges are automatically posted to the project and all purchase activities can be viewed online.
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OSP sends an e-mail monthly to all PIs whose projects have financial activity. This message provides a link to the online Month End Financial Statements (eMEFS). This tool can be used to reconcile project expenses and commitments at the end of each month. You can also view and print the project financial summary and various detailed personnel and non-personnel reports. If cost sharing is required on the project, these expenses can be verified.
The PI Portal can assist in monitoring financial, personnel and administrative award information. You can review personnel and non-personnel commitments and expenses, check that any significant award modifications have occurred, verify the current investigators’ effort percent and COI status are current and verify that projects are in compliance with all terms and conditions. View this training session on Financial Management for Clinical Trials (Part 1) and (Part 2) discussing the use of PI Portal and Workday.
Access the transcript for Part 1 (Word Doc)
Access the transcript for Part 2 (Word Doc)
Access the PI Portal
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.
Packaging
Study drugs will often be packaged to protect the product, ease dispensation and to preserve blinding when necessary. Typically the packaging will offer a place to record the study participant ID.
Receipt
When a study drug is received at the study site, it is important to inspect the shipment in its entirety. The packing slip should be compared to both the order form and the contents of the shipment. Often study sponsors will require that the packing slip be signed, dated and returned in order to acknowledge receipt of the shipment. If it appears that the shipment is incomplete or was damaged in transit, contact the sponsor immediately.
Storage
Storage instructions should be included with the shipment, including specifications for temperature ranges. Study drugs should always be stored in a secure location, either at the study pharmacy or in a locked cabinet within a separate locked room. Temperature logs should be maintained in the storage area to ensure that the product remains viable.
If a study drug requires storage in a refrigerator, the refrigerator should have a lock on it and should remain free of food. This means that study drugs cannot be kept in the break room refrigerator. Likewise, lunch cannot be kept in the study drug refrigerator.
Dispensation
The tracking of study drug dispensation can become complicated with many study participants over the course of a lengthy trial. Meticulous records are required in order to be compliant with accountability. Study drugs received from the sponsor should be tracked, as well as drugs dispensed to study participants.