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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 Participant Recruitment Unit is responsible for: 1) Collecting and communicating enrollment data with the CTSA Network and WFBH leadership for site selection and planning. 2) Educating study teams to identity, recruit, and manage participants. 3) Acting as the central clearinghouse for study advertising including Be Involved Website and Hotline. 4) Developing and deploying best practices and strategies to improve recruitment rates. Please request theses services through the CTSI Service Request Form

Recruitment Best Practices Education is vital to ensure study staff are prepared to enroll and manage participants. Recruitment information requests allow study teams to learn how to utilize Research Match and requesting data being collected on studies or departments.

Translational Data Warehouse identifies patients in WakeOne meeting eligibility criteria. We can answer recruitment feasibility questions by providing the number of eligible participants before study approval. We can generate an IRB-Approved patient information report such as address or primary physician that can be used to recruit participants directly.

Recruitment Plan Consultations are meetings led by the Recruitment Coordinator to help study teams calculate recruitment rates, review eligibility requirements, determine enrollment feasibility, identify physicians treating the target population for referrals, review advertising materials/methods, and connect studies inter-departmental services.

Be Involved is the official site to learn more about WFBH research studies. Users can search studies by condition to learn the study’s purpose, eligibility, and compensation. The “I want to participate” button at the bottom of each page will allow users to send their contact information to the listed study coordinator. Users can register to receive alerts when new studies are published. Study teams can request study page changes that align with IRB. 

Advertisement Design and Marketing requests will link study teams to WFBH branded templates and IRB advertising requirements to guide the creation process. Ads require approval by Creative Communications by sending it to brandchampion@wakehealth.edu and IRB. Once approved, studies can be posted on WFBH social media sites and eBulletin or we will send our external advertising contact list including news stations, radio, magazines, bus placards, and more.

Support Services

Maya Angelou Center of Health Equity offer services to support the recruitment of special populations such as older adults, children, and minorities. Services including consultations, language services, research navigation, and voucher programs.

Network Research Team assist studies that are conducting research outside of WFBH main campus.

Trial Innovation Network is a collaborative initiative within the CTSA Program which houses the Recruitment Innovation Center (RIC).  RIC offers five services: cohort assessment, feasibility assessment, recruitment materials, recruitment planning, and community engagement studio. The Recruitment Toolbox allows hubs to share resources and tools.

Communication, Marketing, and Media is the clearinghouse for community and sponsored events. Study teams can volunteer to host the booth for events like the Komen Race for the Cure, El Buen Camino, and the Winston-Salem Open which hosts 40,000 attendants. Study advertisements can be decimated and discussed to increase awareness and enrollment.

WakeOne Support helps study teams set up Best Practice Alerts in WakeOne that will flag patients that are eligible for studies when they are visiting their doctor. It can also be used to send study information to eligible patients through their MyWakeHealth accounts.

For more information, call us at 336-716-2121 or email us at BeInvolvedRegistrar@wakehealth.edu


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