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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

Recruitment Resources

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.