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Clinical Trial Participant Management

Through the Office of Clinical Research, the CTSI provides many resources, tools, and services for clinical trial participant management. This includes assistance with participant recruitment and guidance on regulatory requirements, such as Informed Consent Forms. Learn more below.

Informed Consent Documents

Medical Center Policy Makes Uploading Consent Documents into On-base Section of Subjects’ Medical Records Mandatory for Trials

This is a reminder that since the implementation of WakeOne, we have a secure area for the storage of research informed consent documents. The section in On-Base called “Consents-Research,” where research informed consent forms are uploaded, is accessible to those treating a patient but data in that section will not be routinely sent to insurance companies or other requesters.   Therefore,  having consent forms in this area protects participants from inappropriate outside disclosure of their research information, but also provides their clinical treatment team with important information that may affect their care.  Medical Center policy on Investigational/FDA Conditionally Approved Medical Devices has been revised and signed by the Chief Compliance Officer, Yates Lackey.  This revised policy makes uploading research informed consents into On-Base mandatory in certain circumstances.  This requirement must be followed for all treatment trials and any other interactive human research that requires a flag in WakeOne.
 
The revised policy can be found here: Investigational/FDA Conditionally Approved Medical Devices Policy
 
Because of CMS requirements that mandate access to the consent document if the standard treatment pathway is altered by a clinical trial, all consent documents for this type of study should be uploaded into the system.  If you do not have all of the consent forms uploaded into On-Base for studies that are, or were, registered in EPIC (i.e. with a research flag) and alter the standard treatment pathway, please ensure that this is done as soon as possible.  Not having these documents in the system during an audit by The Joint Commission or CMS officials may result in severe penalties to the Institution.

See Uploading ICFs in WakeOne for information on uploading informed consent documents into the On-Base section of subjects’ medical records,either by scanning research consents into WakeOne or uploading research consents into WakeOne using email.

If you do not have a WakeOne compatible scanner, you may also send your informed consent documents to Health Information Management (HIM) for upload.  Please make sure that HIM personnel can determine which record each form needs to be uploaded into.

Please submit all patient reconsent forms through PeopleSoft as well. 

Contact Joseph Andrews, PhD with questions at jandrews@wakehealth.edu.

Integrating Special Populations Services

The Integrating Special Populations (ISP) Program of the Maya Angelou Center for Health Equity (MACHE) and the Clinical and Translational Science Institute (CTSI) offers a number of services to researchers and research staffs who are interested in working with special populations, as well as research participants representing ISP that would like to participate in clinical research. Learn more about the ISP Program or about the available services below. 

Language Services 

The ISP Program, in collaboration with Language Services, will expedite requests for document translations with a short turnaround. We offer on-site interpretation with certified staff to help studies with Spanish speaking participants. If interpreters are not available, research staff can request the use of the Video Remote Interpreting system to streamline interpretation with participants in more than 20 languages, including sign language. Learn more in the introductory video

Consultations

We provide feedback on recruitment strategies for including special populations, review and advise on advertisement materials and media outlets. We also provide feedback related to diversity sensitivity and provide strategies to increase the interest of special populations to participate in research. 

Voucher Program 

We provide support through funds for transportation, study advertisement and other appropriate services to minimize participation gap. These resources may help studies increase the participation and retention of special population participants. Eligible studies aim at increasing special population participation (seniors, pediatrics and underrepresented minorities) and have a financial need. 

Studies interested in the Voucher program must complete the CTSI Service Request Form, select "Special populations" and "Voucher Program." Once the Integrating Special Populations Program receives requests, studies will be invited to complete an application. Approved studies must sign the Program Award Agreement.

Navigation 

We support studies with recruitment, consenting and navigation of Spanish speaking participants. We help guide Spanish speaking participants throughout the research process by offering moral support and continuous interpreting. We also offer other types of assistance to research staff with special populations as needed. 

To request services, please use the CTSI Service Request Form. For questions, please contact Keren G. Ferris at kferris@wakehealth.edu or 336-716-0040.

Participant Recruitment Unit and Toolbox

The Recruitment Unit is responsible for: 1) assuring that reasonable recruitment goals are set and achieved for Wake Forest Baptist Health research, 2) collecting and communicating recruitment and enrollment data with the CTSA Network recruitment Centers for site selection and recruitment planning, 3) act as a central clearinghouse for advertising, be Involved, and Research phone line, 4) develop and deploy services to improve recruitment planning strategies, study awareness, and participant identification. The CTSI encourages studies to request these services to reach their enrollment goals through the CTSI Service Request Form. For more information, please contact beinvolvedregistrar@wakehealth.edu or 336-716-2121.

Patient Data Pulls
The Recruitment Unit utilizes the Translational Data Warehouse to identify patients in WakeOne that meet a study's Inclusion/Exclusion criteria. It can provide the number of eligible participants for feasibility questionnaires before study approval or a report of IRB approved personal information that can be used to recruit participants

Be Involved
Be Involved is a web-based interface for potential participants to search for recruiting studies at Wake Forest Baptist Medical Center. Users can then send their contact information to the listed study coordinator through the "I want to Participate" button or register to receive alerts of the studies that fit their disease or health areas of interest. If a study wishes to appear on Be Involved, please follow these instructions.

Advertising
Use these customizable brand-compliant templates available through creative communications to create flyers, brochures, newspaper ads, and post cards. The Readability Calculator improves the language used in advertisements to help it connect with the target audiences. View examples of recruitment materials here.

All marketing materials must be approved by Creative Communications and IRB. After approval, the Recruitment Unit can help advertise studies through WBFH eBullitin, WFBH Social Media, or Community Engagement events. other services include the prevision of local TV, radio stations, newspapers, bus placards, colleges, and magazine contacts that can help promote studies.

Recruitment Database
Research Match is a national recruitment website funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program.

Recruitment Planning Consultations
Consultations include the calculation of appropriate recruitment rate to reach enrollment goals, recommendation of other recruitment services, review of inclusion/exclusion criteria, provision of contact information to connect with referring doctors, and review of advertising materials, methods, and outlets. If the study is recruiting minorities, older adults, or children, please see the Maya Angelou Center for Health Equity (formerly Integrating Special Populations Program) section for consultations.

Processing Patient Payments

To manage patient payments, have subject complete a Substitute Form W9: Request for Taxpayer Identification Number.

To request a new vendor number, complete the New Vendor Request Form and email both completed forms to WFUBMcap@wakehealth.edu. WFUBMCAP will email back with vendor number.

Research Participants and WakeOne

A patient's participation in a clinical study should be logged in their Wake One patient record. 

The purpose of the research subject flag is to identify research participants who have a potential safety or billing risk. To help identify and track these participants, subjects must be flagged in the Electronic Medical Record (EMR) and billing systems. Therefore, it is important for research study staff to notify the CTO to assist with this process.

The following instructions are provided for logging participant activity in WakeOne:

You can also refer to WakeOne Tips and Tricks