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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 Identification and Recruitment Unit

The Participant Identification and Recruitment Unit is responsible for assuring that reasonable recruitment goals are set and achieved for CTSI clinical trials. The Recruitment Unit will utilize the Translational Data Warehouse to identify potential research participants and share eligibility data with the CTSA Network Recruitment Centers in a de-identified, aggregated format for site selection and recruitment planning; develop and deploy services and tools to support recruitment planning strategies, improve the identification of potential participants, and allow participants to identify study opportunities; act as a central clearinghouse for advertising and recruitment efforts with a focus on engaging special populations; ensure that patients’ privacy is protected and all means of contact occur in an ethical manner following best practices.

For more information, please contact Selvin Ohene at sohene@wakehealth.edu or 336-716-9134.

Participant Recruitment Toolbox

The Recruitment Toolbox provides researchers and staff easy access to resources in order to create recruitment flyers, announcements, and advertisements for study recruitment and enrollment. If you have any questions or would like to schedule a consultation with the Recruitment Team, please submit a request through the CTSI Service Request Form.

Be Involved
Be Involved is a web-based interface for potential participants to search and register for actively recruiting clinical trials at Wake Forest Baptist Medical Center. The registration component allows individuals to provide contact information as well as identify specific disease or health related areas. Visit the Be Involved website.

Study staff who want a summary of their study on the Be Involved website can submit their study from the eIRB to the CRMS. Review more detailed instructions on how to submit a study to the Be Involved website. For questions, please contact beinvolvedregistrar@wakehealth.edu or 336-716-2121.

Customizable Templates
Use these customizable brand-compliant templates available through Creative Communications to create flyers, brochures, newspaper ads,* and post cards.* 
*small fee for prepress services

Advertising Kit
The Advertising Kit contains contact information for local TV, radio stations, newspapers, and magazine publications to promote your research study.

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

Other Tools

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