Survey, Recruitment, and Biospecimen Collection Shared Resource (SRBSR) Services
Study Planning and Survey Design
The SRBSR provides advice and consultation services on most of the components of study implementation. SRBSR can assess the number of available cases, the feasibility of accrual, and biospecimen availability as part of planning new applications. SRBSR also consults investigators survey design, measures for use in patient surveys, subject tracking and data management, and regulatory issues.
The SRBSR advises investigators on the choice of available, validated survey instruments and items for capturing patient-reported health data based on the objectives of each study.
Eligibility Screening and Subject Recruitment
Investigators who need recruitment support for studies are asked to complete a Recruitment Request Form, including documentation of IRB approval for their study, and submit this form to Ms. McGuire.
The SRBSR manages the IRB-approved Georgetown Medstar Research Registry (GMR2) protocol. This registry allows Investigators from various disciplines to have ready access to a registry of individuals with cancer or at risk for cancer with high quality baseline data linked to biospecimens who have also consented to participate in additional research. Trained SRBSR recruiters screen all potential subjects coming to clinics (medical and surgical oncology clinics, hematology, and breast imaging) at either MGUH or MWHC using MedStar scheduling systems and then approach them in the clinics to administer the GMR2 universal Informed Consent. The GMR2 consent form includes separate consent for tissue, non-tissue biospecimens, and permission for re-contact by SRBSR and other Investigators and medical record release. Subjects are asked if they agree to be contacted for existing and/or future research opportunities in which case they may be triaged into subsequent studies. Data are entered into SRBSR databases to allow for rapid triage into existing Investigator studies.
Currently, the number of registered participants in the GMR2 is over 3,000 subjects. The GMR2 enables access to data for study planning, to facilitate and harmonize recruitment across multiple investigators recruiting in the same clinics, and to permit access to biospecimens for preliminary explorations. This is a great resource to support Investigators to document the feasibility of recruitment and for characterizing the MedStar patient population.
For All New Projects:
The SRBSR Director of Operations Colleen McGuire queries the GMR2 database for subjects who have already given permission to be re-contacted for additional studies and meet study-specific eligibility criteria. If participants had previously consented to be contacted by investigators, SRBSR recruiters explain the study and then consent subjects as necessary using specific study IRB-approved informed consent forms. Recruiters can either collect data (administer survey and/or obtain biospecimens) or, optionally, provide information on eligibility and refer to study-specific staff to conduct all follow-up and data collection activities under the guidance of the study PI. When needed, a Recruitment Triage Committee prioritizes the recruitment of subjects to studies with overlapping eligibility.
For studies that require recruitment of subjects who are not currently registered in the GMR2, trained SRBSR recruiters are able to screen all potential subjects for specific eligibility through MedStar scheduling systems and then will consent any identified eligible subjects in the clinic. SRBSR recruiters can either collect data (administer survey and/or obtain biospecimens) directly, or, optionally, provide information on eligibility to study staff who can then conduct all follow-up and data collection activities for a particular study. The PIs or their staff are requested to send accrual updates to SRBSR to track participant accrual.
Recruitment and trial management is not provided for treatment clinical trials, as that is the role of the Clinical Research Management Office at the GUMC. Also, recruitment outside of clinical settings (e.g., in local community settings) is not provided by the SRBSR.
Survey Administration on Electronic Platforms
Participants enrolled in the GMR2 are asked to complete a core questionnaire (CQ) through REDCap, which includes questions on demographics, cancer risk factors, quality of life, and medical history. The questionnaire is modular; questions can be added or modified. Participants can complete the questionnaire on an iPad at the time of their initial visit or at a return clinic visit. SRBSR also sends a unique and secure Web link to subjects to allow participants to complete the questionnaire remotely. SRBSR recruiters are also available to administer study specific questionnaires when applicable.
The SRBSR also provides investigators with GMR2 core questionnaire data as requested.
For each new project, the SRBSR has the ability to design and implement novel electronic surveys that use either fixed (desktop) or mobile (tablet, smartphone) platforms, primarily employing the Research Electronic Data Capture (REDCap) software or Tonic Health
Development of Study Tracking Databases
The SRBSR designs, builds, and maintains customized database systems to track study participants across time and also records administrative data elements for later merging with survey data. The SRBSR staff can track subjects for investigators, or trains study staff in the use of these systems for day-to-day tracking and report generation. SRBSR maintains and revises tracking systems as necessary as part of the ongoing support of studies.
SRBSR recruiters obtain biological samples when possible, including tumor and non-tumor tissue; blood samples; buccal swabs; hair, saliva and urine samples; and nail clippings. Up to 50 mL of blood are taken for the extraction of blood products, including serum, plasma, buffy coat, RBCs, PBMCs and blood clot. Tissue products are stored by the Histopathology & Tissue Shared Resource (HTSR). The non-tissue products are processed and stored by the Tissue Culture and Biobanking Shared Resource (TCBSR) and are available as frozen aliquots. Biospecimens can be collected at multiple time points, enabling the serial measurement of biomarker levels in relation to surgery or other treatments.
The SRBSR now consents patients about to undergo surgery, in same-day surgery or the pre-op holding area. For SRBSR-supported studies that require both archived tumor tissue and other specimens, the SRBSR works with the HTSR to identify consenting subjects and obtain optimal specimens, including from subjects who undergo surgery at outside institutions.
Investigators seeking SRBSR-collected biospecimens query repository information on the Georgetown Innovation Center for Biomedical Informatics dashboard. They must complete request forms and have IRB approval or waivers for their specific study. The SRBSR manager, in coordination with the TCBSR and HTSR managers where applicable, then determines sample availability. In instances where biospecimens are limited, the Biospecimen Use Committee (BUC) also must review and approve the request.
Medical Record Abstraction
Pathology reports and other related medical records are routinely abstracted for subjects who have consented to the release of such records to confirm reported diagnoses and procedures. Relevant data points are extracted from the reports and recorded in the corresponding databases.
Data Entry, Merging, and Dataset Preparation
The SRBSR works closely with other shared resources to obtain and combine data from multiple sources for merging into final analysis data sets that may include any combination of patient survey data, EHR data and biospecimen data. The SRBSR provides quality assurance measures during data collection with validation algorithms and uses double data entry and range checks to reduce errors. The SRBSR is responsible for scoring survey scales for inclusion in analytic datasets. The SRBSR provides technical expertise for the organization and preparation of study datasets from other large secondary databases including tumor registry, claims, and EHR data.
Unique identification numbers enable SRBSR staff to merge survey and/or biospecimen data with EHR data such as cancer pathology, staging and treatment regimens. These abstracted data are obtained online from systems covering inpatient and outpatient/ambulatory services (Amalga and Cerner), and outpatient oncology (ARIA) at MGUH and MWHC. The SRBSR uses advanced data manipulation techniques to validate study data; gather, track and merge data from multiple sources; provide ongoing data set maintenance; and prepare final data sets for statistical analysis.