Office of Human Research Services - Services
Protocol and consent form submission: OHRS staff assist investigators in preparing protocol documents consistent in all of the CINJ “template” areas and consent forms that comply with Federal Regulations and RWJMS IRB standards. Following approval by the Scientific Review Board (SRB), support is provided for protocol and consent form formatting, preparation of IRB submission materials and submission of protocols to appropriate review committees, including CTEP and the Food and Drug Administration (FDA) if an Investigational New Drug (IND) application is required.
Pre-study activities: OHRS develops study-specific eligibility check lists and other tools (e.g., patient calendars, standard order sets, medication diaries, etc.), assembles study-specific electronic case report forms (e-CRFs), prepares a data capture plan with the principal investigator and coordinates the training of personnel who are involved in the research. OHRS regulatory affairs distribute protocols and sample consent forms to participating institutions. Documentation of IRB approval and approved consent forms are collected and reviewed by regulatory staff before participating centers begin enrollment.
Activation meetings: OHRS schedules activation meetings for all new studies with the protocol team, which includes the principal investigator, co-investigators, research nurse clinicians, oncology clinical research coordinators, a treatment nurse, and Research Pharmacy Shared Resource staff. The purpose of this meeting is to review the protocol, define tasks, and identify any special requirements. OHRS multi-center staff conducts activation visits (or webinars) at CINJ Oncology Group institutions and collaborating cancer centers before patient enrollment may begin.
Communications: OHRS communicates the status of protocols to CINJ investigators on a continuous basis as a part of their participation in the Disease Specific Group (DSG) meetings. Approved protocols, consent forms and other protocol-specific documents are uploaded by OHRS regulatory personnel to the web-based OnCore® system. All CINJ clinical trials, once activated in OnCore®, are automatically posted on the CINJ web site (www.cinj.org).
Patient screening: OHRS research nurse clinicians evaluate and verify patient eligibility for participation in research trials. A research nurse clinician reviews patient data before the patient’s visit to screen for eligibility and compliance with protocol requirements. Research nurse clinicians participate in the multidisciplinary clinics and in the DSG meetings to assist in patient enrollment by making physicians aware of patients who may be eligible for clinical trials.
Obtaining informed consent and verifying eligibility: Once a CINJ faculty member has evaluated a patient for an intervention trial, a research nurse clinician assists in describing the study to the patient and answering questions. Consent forms are only available via OnCore® thus assuring that the correct version is always used. Research nurse clinicians ensure patients meet all eligibility requirements, the consent form is signed and dated, protocol enrollment forms are complete and all required pre-enrollment results are obtained, reviewed, and documented in the medical record before enrollment.
Centralized patient enrollment: All patients enrolled on CINJ intervention trials must be registered through the OHRS, including enrollment from collaborating institutions within the CINJ Oncology Group and other cancer centers. Eligibility of patients enrolled at CINJ is confirmed by reviewing source documentation before patient registration. A research nurse clinician confirms eligibility and an oncology clinical research coordinator completes the registration process. When a patient is identified for trial participation at a collaborating center, a completed eligibility checklist and signed consent form are sent by facsimile to OHRS. OHRS personnel complete the registration process with personnel from the collaborating center. Patients are not considered on-study until registered in the OnCore® database.
Study tools: A number of study tools are created during the activation phase of each clinical trial to assist in efficient scheduling and collection of needed data. For example, oncology clinical research coordinators create calendars of interventions and data collection points. Study calendars are created in the OnCore® database to facilitate data collection requirements. A planned visit report in OnCore® assists in ensuring the evaluations are obtained in accordance with protocol requirements. For the CINJ Clinical Investigations Program, study calendars are integrated into the electronic medical record (EMR), Sunrise Disease Manager-Oncology. This EMR is currently being replaced by ARIA and clinical trial data is being migrated to this system. OHRS personnel customize this system on an ongoing basis to facilitate the operation of CINJ early trials. Research nurse clinicians assist in writing orders and ensuring that patients comply with protocol requirements. Research nurse clinicians triage problems that arise, such as patient-reported adverse experiences, for discussion, evaluation, and action by the principal investigator.
Reporting serious and/or unexpected adverse events: OHRS coordinates completion and submission of serious adverse event (SAE) reports to the IRB and sponsors in accordance with all Federal requirements. Research nurse clinicians identify SAEs, and ensure that SAE information is entered into the OnCore® database after review with the PI or co-investigator. A report is then generated from the database for investigator review and sign-off. The OHRS Manger of Quality Assurance and Data Monitoring receives all signed SAE reports and is responsible for updating OnCore® with new information provided by the investigator and submitting the report to the IRB when IRB submission criteria have been met. SAE reports submitted to the NCI (i.e., for cooperative group studies and CTEP trials) are entered into OnCore® and NCI’s AdEERS system by an oncology clinical research coordinator. Follow-up reports are submitted when additional relevant information becomes available. SAEs occurring at CINJ Oncology Group sites and participating cancer centers are reported to the OHRS on a MedWatch report. The data from the Medwatch report is entered into the database. During on-site monitoring visits to CINJ Oncology Group sites and other cancer centers, OHRS personnel ensure that all SAEs have been reported to the IRB. SAE summary reports are available in OnCore® and are reviewed regularly by the HROC and CINJ’s External Data and Safety Monitoring Committee.
Data collection and monitoring: Information from medical records are currently transcribed onto electronic case report forms (e-CRFs) that mirror the NCI standard case report forms, and the CINJ informatics personnel are working to automate this process from ARIA. The e-CRFs are used for all CINJ investigator-initiated studies, including CTEP studies. For CINJ multi-center studies research staff at the collaborating institution complete the e-CRFs. Data entered into the database from collaborating institutions is reviewed frequently by CINJ Oncology Group clinical research associates (CRAs). Incomplete or missing data prompts follow-up calls or electronic queries. Data accuracy at collaborating institutions is verified by the CINJ Oncology Group CRAs through on-site review of source documents. Monitoring visits to affiliate institutions in New Jersey occur frequently, usually every two months. The monitoring schedule is highly dependent on the amount of data requiring source document verification. Currently, monitoring visits to participating out of state cancer centers occur annually.
The mechanisms of data collection and verification described above are designed to prevent protocol deviations. Protocol deviations are discovered by research nurse clinicians or oncology clinical research coordinators and entered into the OnCore® database. The Human Research Oversight Committee (HROC) reviews all deviation reports. OHRS also ensures that the deviation is reported to the IRB when IRB criteria have been met, and ensures the principal investigator’s action plan is appropriate.
Quality assurance: Investigator-initiated intervention trials are audited in accordance with CINJ’s Data and Safety Monitoring Plan. OHRS houses and oversees the auditing process. Audit reports are submitted to HROC and the IRB. If corrective actions are requested, the principal investigator must submit a response to HROC, and OHRS will help the PI, if needed.
Regulatory activities: The OHRS Regulatory Affairs service area assists investigators with preparation of IRB applications, ensuring consent forms contain all essential elements and are in compliance with UMDNJ IRB requirements, and a variety of other activities. The Regulatory Affairs service area maintains a file for each study containing copies of all protocols, consent forms, IRB correspondence, investigational drug brochures and other study-specific documents. For multi-center studies coordinated by CINJ the Regulatory Affairs service area obtains IRB approval documentation and the IRB approved consent form from each center before any enrollment.
Investigational new drug (IND) submissions: Individuals from OHRS work together with the Research Pharmacy Shared Resource, to assist investigators in obtaining cross reference information with drug manufacturers, preparation, filing and reporting of protocols conducted under an IND.