Active Trial
Active Trial
Key steps to take during an active trial.
Study Implementation Meeting
After a study receives IRB approval, it is important to have a formal study implementation meeting with all internal key personnel. The focus of the implementation meeting is to ensure that all budget, contract, nursing, data collection, laboratory and other protocol-specific issues have been resolved prior to opening a study to participant accrual. This is also the opportunity to ensure that all key personnel have completed any protocol-specific training and are familiar with the expectations of the protocol and investigator responsibilities and the delegation of responsibilities.
The implementation meeting is a detailed planning session involving the key personnel associated with the study. Typical attendees of an implementation meeting include but are not limited to research staff (clinical research coordinators, clinical research nurses, data coordinators, clinical research managers and regulatory compliance officers, PIs and sub-investigators), contract and budget analysts, clinical staff (clinic/unit nurse manager, nurse specialists, unit PCRM, clinic/unit staff RN), pharmacist, clinic and research lab personnel, hospital administration, financial counselors and pre-certification/pre-determination representatives.
The agenda may include, but is not limited to, the items below:
- Key study personnel with contact information
- Study overview including objectives, design and purpose
- Participant eligibility and registration requirements
- Study-specific tasks to be completed with timeline, feasibility and logistical requirements
- Investigational product management, storage, ordering and shipping requirements
- Required source documentation and examples of documentation tools
- Specific nursing or ancillary staff requirements
- Financial pre-determination or pre-certification considerations
- Data elements collected and timeline requirements for data submission
- Serious Adverse Event (SAE) reporting guidelines
- Other processes or procedures that must be defined and implemented prior to enrolling study participants.
Study Visit Scheduling Templates
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Many human subject protocols require participants to be scheduled for specific research visits. The number and length of time required for a research appointment to occur is highly dependent on the specifics of the study design. The specifics of the appointment are highly dependent on the location of the appointment. Appointments can occur in inpatient units, outpatient clinics, lab draw locations, diagnostic testing locations, research labs, Clinical Research Center (CRC), at the participant’s home or a neutral site convenient for the participant. The visits where the study will occur must be listed with the IRB.
It is important to set the expectations of each visit for the participant. For example, where the visit will take place, how long the visit will take, tasks to be completed at the visit, what tasks are clinical vs. what is research related, special instructions the participant must follow prior to the visit, directions and parking information, whether or not compensation for time or parking will take place and who will be involved in the visit. This should all be included in a confirmation letter.
Access Screening Letter (Word Document)
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Once the visit is scheduled, follow-up contact within a week prior to the visit by a phone call to the participant. It is essential to reinforce the requirements of the study and ensure there has not been any changes since the last time you spoke (broke a leg, new infection, changed medication). Some of these changes might make the patient ineligible and would be better to catch ahead of time.
It is important to be understanding of the participant’s personal schedule and to help identify research visit times that are convenient for the individual to commit to without sacrificing protocol compliance. If the study has multiple visits and you know the study visit windows, it is good to provide it to the subject to help them plan ahead.
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Prior to each study visit, the research team must be prepared for all known and unknown tasks that may need to be completed per protocol. If applicable, physician orders need to be completed and authorized for lab draws, study medication and additional testing; research lab kits should be prepared and available to the appropriate clinical team drawing the samples; participant questionnaires should be prepared; flowsheets required for research documentation should be made available to the appropriate team members; and any end of study visit items should be readily available if the participant decides to withdraw from the study or is removed from the study due to adverse events or investigator discretion, etc.
Recruitment Resources
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ResearchMatch is a complementary participant recruitment tool that was created through the collaboration of institutions involved with the CTSA Consortium, including The Ohio State University and Nationwide Children’s Hospital. ResearchMatch aims to ‘match’ two groups of people: ResearchMatch Volunteers (individuals who wish to learn about studies that might be of interest to them) with ResearchMatch Researchers (researchers who register their study through this tool).
ResearchMatch can be used as an additional recruitment strategy for your study. There are thousands of volunteers registered in this database and about 12% of the national registry is located in Ohio; 10% are within 25 miles of Ohio State and Nationwide Children's Hospital. ResearchMatch can be included in the initial protocol submission and in future amendments as a specific participant recruitment tool.
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StudySearch is a web-based application that provides a searchable listing of research studies at Ohio State and Nationwide Children's Hospital seeking volunteers. StudySearch contains basic descriptive information about each study including study title, the purpose of the study, eligibility criteria and study personnel contact information. A user-friendly keyword search feature is also available which can easily search conditions, interventions and other eligibility criteria.
When you register your trial with ClinicalTrials.gov it will automatically download information into lay language for this listing. According to the Food and Drug Administration Modernization Act of November 1997, trials "of experimental treatments for serious or life-threatening diseases or conditions” must be registered with ClinicalTrials.gov. If your research study is not required to be registered with clinicaltrials.gov then your research study can be added to the StudySearch database by the CTSI team.
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The Center for Information and Study on Clinical Research Participation (CISCRP) is a first-of-its-kind nonprofit organization dedicated to educating and informing the public, patients, medical/research communities, the media and policy makers about clinical research and the role each party plays in the process. This organization is a good resource for research participation promotion.
Retention
At the time of obtaining informed consent, it is important to ensure that the potential participant understands what level of commitment is necessary to be involved in the research study in addition to the key elements of informed consent. The expectations of the number of visits, length of visits, tasks involved at each visit, duration of the overall study and potential costs should be clearly discussed with the potential participant prior to enrollment. If the trial is a randomized placebo or comparative controlled study design, then extra attention should be given to this discussion. All of these aspects of participating in a research study can dramatically impact the participant’s willingness or ability to commit to the full length of the study.
Study participation is completely voluntary and participants can withdraw from the study at any time. Providing consistent and informative visit reminders in the form of a letter and phone call can be helpful to participants and may positively contribute to participant retention. Also, writing protocols that allow flexibility in study visits to accommodate the busy schedules of participants may also yield a higher retention rate.
Clinic Appointment vs Research Appointment
Many studies at Ohio State recruit research participants from patients that are already scheduled for healthcare visits in the medical center or cancer center. If the study design is such that these visits can serve the dual purpose of study visit and doctor visits, then scheduling is relatively straightforward and involves coordinating with the clinical treatment team. Clinic and diagnostic testing appointments are scheduled in IHIS, the provider scheduling database. The research team can review the electronic medical record, for specific information on the visits scheduled. It is important to review the participant visits often, as they could be altered or canceled by someone else which may result in protocol compliance concerns or impact the anticipated activities for that day.
For research appointments that need to be scheduled in the Ohio State hospital or clinics, independent of the patient’s medical appointments, most of the scheduling is done by the hospital schedulers or you might have a point person to ensure you have the correct staffing needed for the research visit. However, it is still the responsibility of the research staff to communicate the specifics of the protocol visit, including the timing of the visits scheduled, how long visits are expected to take, complete any paperwork necessary, obtain physician order for lab or special testing that needs to be performed at a given visit.
Many studies require that research visits take place in a location that is specifically equipped to carry out the research protocol. Space may be designed to administer specific computer questionnaires, to conduct interviews in a private setting, to be proximal to labs for obtaining and processing blood or other biological specimens or to medical equipment like research CT scans or MRI equipment that cannot be moved. Sometimes certain controlled environments or conditional experiences are part of the research visit. These visits will be arranged with the key research staff involved in the research visit and may not be formally scheduled in the medical center scheduling system. This can cause patients to get reminder calls about a research procedure that happens later in the day and it is separate from the time/location you had discussed for the consent procedure visit to take place. It is essential to send a research confirmation letter that lists the procedures to help clarify to the who, what when and where for the entire study visit.
Lab Review Documentation
When you receive lab reports your investigator will need to document that they have been reviewed. On any abnormal lab value the investigator must document if it is clinically significant. If it is documented as clinically significant then you will need to create an Adverse Event form. Sometimes the lab is related to other areas of the patient’s medical history so if it is abnormality, it can be documented as such. Great investigators write on the first batch of labs what the abnormal lab value correlates with in subject’s medical history (i.e. elevated glucose=subject is diabetic) so that reviewers can see that they reviewed all abnormalities seriously.
Below is a link to a sticker you can attach to printed reports that quickly documents that the investigator has reviewed the labs and then have your investigator sign off on it.
Scheduling Off-Site Research Visits
There are research studies that allow the visits to take place in the participant’s home or another neutral location that may be more convenient for the participant. Off-site study visits pose some additional challenges to the research staff in the form of feasibility and safety.
Before scheduling a home visit, research staff must assess if the visit tasks can be accomplished in the specific location. For example, is there a workspace sufficient to carry out lab draws and physical examinations, are there electrical outlets for medical equipment or laptop computers, etc.
The distance away from the study center needs to be taken into consideration as many studies have a travel limit for outreach research staff. Distance can also cause some feasibility issues such as timeframe that blood specimens must be processed to maintain the integrity of the sample. Other things to consider include how the data will be transported to and from the home or off-site study visit. If laptops are used to transport data, they need to be encrypted to ensure HIPAA compliance.
Safety is also a necessary consideration when conducting home visits. When a member of the research team goes to an unfamiliar area to conduct a study visit, at least one other coworker should know that the appointment is occurring. The researcher should communicate with the research team immediately before and after the study visit occurs. The safety of the research staff should always be the primary consideration over the completion of a study visit outside the research study center and appropriate judgment should be utilized.
Fiscal Management/Invoicing
Grants that have a fixed effort will be invoiced by the Sponsored Program Office. Once your department appoints the specified effort or charges to the grant for approved supplies/patient care. If the study is fee for service the SPO will not have a way of knowing what has been completed for billing. If you work with the CTO/CCRM they will take care of invoicing. If you do not work with theCTO/CCRM the invoicing falls on the investigative team. Talk with your Sponsored Program Officer about the contract requirements and invoice templates.
Monitoring Accounts and Receivables
There are several groups depending on the funding type and department you are within that can assist with monitoring research accounts.
- The OSP is a great resource for managing and monitoring your research accounts
- Grants Management Office (GMO), In the College of Medicine, helps with grants/awards that are not industry funded and they work more granular on the projects than the OSP
- Other departments outside of College of Medicine have their own type of grants structure on their fiscal team but you would still have a sponsored program officer with OSP
- The Center for Clinical Research Management (CCRM) is used for most groups within the College of Medicine and they assist with industry sponsored and fee for service grants
- The Clinical Trials Office (CTO) provides a centralized resource for the management of clinical trials in the Comprehensive Cancer Center
It is important to understand the infrastructure and where to direct questions or concerns on projects. There are different management portals available, access depends on staffing roles/responsibilities. If additional access may aid with job responsibilities, first talk with the PI and once they approve, the staff member and PI should discuss with the department administrator.
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The PI Portal provides secure online access to proposal, award, and sponsored project information.
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e-Activity is a reporting tool that provides access to proposal, award and expenditure activity. Access is required to view e-Activity in the Reporting and Analytics Environment (RAE) request RAE access
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Reports are integrated into all aspects of using Workday. Access a report directly by searching for the report name or keyword, and find reports built into dashboards and embedded in business processes.
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The PI dashboard in Workday allows PIs to view multiple funding sources in one place. It includes:
- OSP Grants report, which is a high-level review of awards, their grants and each grant’s high-level financial picture. The data is similar to what is available in the current PI Portal.
- My Tasks, which is a list of technical tasks and reports for OSP managed externally funded awards that are assigned to the PI viewing the report.
- Faculty Financials Tab, which enables the PI to view information on internal (non-OSP) grants to view budgets, expenditures, encumbrances, grant start and end dates for which they are listed as a PI.
- Personnel with Costing Allocations, which enables the PI to view employees in their supervisory organization who report to them across any grant, where they are currently appointed, and their default costing allocation.
- Grants Detail tab, which enables the PI to view line item details on a grant, based on a specific time period
- Other Funding Tab, which enables the PI to access more detailed information on their own regarding other funds assigned to the PI viewing the information, such as startup funds and other possible funds (as decided by Senior Business Officers).
Grants Administrator Dashboard. Is a great resource to fully understand the status of a grant. Study team members need to be granted special access to be able to review.
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If expenses on one project should have been charged to a different project, the PI should contact the department administrator. The administrator can assist with the transfer of charges to the correct project. In order to comply with audit requirements, cost transfers must be completed within 90 days of the cost incurrence, and the reason for the cost transfer must be documented. Cost transfers more than 90 days old require additional documentation and authorization by your department or college and OSP.
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Payroll encumbrances are the most common reason for projects appearing to be overspent. Typically, personnel costs are committed through the end date of a project. However, clinical trial budgets are only increased as funds are received so it is important to consider if additional funds are expected to determine if the project is truly overspent. If there really are insufficient funds, it will be necessary to move the personnel to a department fund and cost share their effort to the award if they continue to work on the award prior to the project end. Contact your department administrator to determine who is able to make that change.