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INVESTIGATOR RESPONSIBLITIES - NEW APPLICATION
A. Submit Massey Cancer Center Protocol Review Form
B. Submit VCU IRB Application
C. Formally Inform Massey Cancer Center Physicians and Research Nurses of Approved Study
D. Obtain Physician Consent
E. Identifying Eligible Patients
G. Accessing Data at Massey Cancer Center
PROGRESS REPORTS AND OTHER REQUIRED COMMUNICATION WITH PRMC
VCU Massey Cancer Center (MCC) has established the Protocol Review and Monitoring Committee (PRMC) in line with mandates from the National Cancer Institute (NCI) regarding research with human subjects. As an NCI designated cancer center, we are required to report on ALL research activities including those that are not considered clinical trials (even those collaborating with outside hospitals, researchers, etc.), regardless of whether you contact patients.
Every cancer-related research project is required to obtain PRMC approval. This is a requirement that is mandated by the VCU Vice-President for Research. The PRMC is responsible for ensuring that all research protocols are scientifically sound and feasible prior to their submission to the VCU Institutional Review Board (IRB) for review. The PRMC primarily reviews therapeutic studies.
The Cancer Prevention and Control subcommittee (CPC) of the PRMC was established to review non-therapeutic studies that do not involve investigational medications or procedures, for example, behavioral interventions and secondary data analysis of patient data. For Cancer Prevention and Control studies approval is obtained from the CPC subcommittee, although the level of review will vary from protocol to protocol. Submitted protocols that are funded by an agency such as the NIH, NCI, or ACS, and have received scientific peer review prior to funding, will not be subject to further scientific review by the CPC, here. (See Expedited review explanation below.)The CPC subcommittee is required to ensure scientific rigor and that CPC studies will achieve their patient enrollment targets without undue burden to MCC patients.
Thus, CPC subcommittee members review all new protocols for their scientific merit, prior to VCU IRB submission. The PRMC and the CPC subcommittee also review to assess patient competition with other protocols. The CPC subcommittee reviews protocol amendments for changes that might affect patient competition.
This manual will familiarize investigators with their roles and responsibilities when conducting human subject research at the MCC. It also reviews procedures for obtaining approval to conduct the study and steps that must be taken prior to patient recruitment. In addition, this manual reviews procedures for conducting research that collects primary data and for obtaining and using secondary data. The specific objectives of the manual are:
To serve as a resource for investigators who seek to conduct human subjects research at MCC.
To facilitate the successful enrollment and conduct of human subjects research.
To establish a consistent protocol to be followed as part of conducting human subjects research.
INVESTIGATOR RESPONSIBILITIES - NEW APPLICATION
All investigational cancer prevention and control related studies conducted at VCU are subject to PRMC CPC approval. MCC’s cancer prevention and control PRMC jurisdiction over review is determined by three criteria:
- All research studies that focus on cancer patients, cancer survivors, their families and caregivers
- All research studies of healthcare professionals providing care to cancer patients or cancer survivors, their families or caregivers
- All research studies that include a primary or secondary cancer prevention component
Approval from the PRMC CPC subcommittee must be obtained prior to submitting the protocol to the VCU IRB. VCU’s IRB requires that the PRMC CPC approval letter accompany any new protocol submission to the IRB. Submitting to IRB without the PRMC CPC approval letter will delay IRB protocol review. If you have any questions about whether or not your study should be submitted for review, please email the PRMC CPC subcommittee coordinator at firstname.lastname@example.org.
To obtain PRMC CPC approval, you will need to submit to email@example.com:
- The Protocol Submission Form [pdf]. Use these instructions [pdf] for completing the Submission Form.
- CITI Training completion certificates for the principal investigator and all study staff if proof of training has not been previously submitted. If you are unsure whether your or a study team member's training is current and on file, please e-mail firstname.lastname@example.org. The Social and Behavioral course is suitable for those conducting Social/Humanistic/Behavioral research with human subjects. Please login here to create a CITI training account. Be sure to select Virginia Commonwealth University as your institution.
Go to RAMS-IRB and create your submission
If this is your first time navigating the RAMS-IRB electronic submission system then here are some helpful hints.
Your completed RAMS IRB submission (email the pdf to email@example.com after completion of forms).
- Your VCU IRB informed consent documents.
- VCU IRB forms.
- Letter or email of clinical support indicating approval from a MCC or affiliated research team or clinician.
To understand the priorities of the PRMC CPC subcommittee reviewers, please see the PRMC CPC review formcompleted by reviewers for each protocol. The VCU IRB Pre-Screening Form could also be helpful in formulating ideas.
Please see a model RAMS IRB submission.
Helpful Hints for navigating RAMS-IRB.
Data and Safety Monitoring Plans
If your study involves a behavioral, psychosocial, or treatment intervention for human subjects (i.e., a clinical trial), your IRB application must include a plan for monitoring participant data and safety, a Data Safety and Monitoring plan (DSMP). More information about DSMP can be found on the MCC website and the VCU IRB website. If you are unsure about whether you need a DSMP please read the information on the NIH website.
DSMP information on NIH website
Additional information and sample DSMPs
Once completed, email all documents to the PRMC CPC Coordinator.
There are three types of PRMC CPC subcommittee reviews – “regular”, “expedited” and “exempt.”
- Regular reviews are sent to peer-reviewers and will be reviewed within 10 days. The reviewers will either approve the protocol or provide specific suggestions for revising the protocol. These protocols are reviewed for scientific rigor as well as feasibility.
- Expedited reviews are designed for peer-reviewed and funded studies and those receiving a Just-In Time (JIT) designation. These will be reviewed within 4 days. For previously peer-reviewed studies, the PRMC review will accept the scientific evaluation of the peer review panel. The purpose of this type of review is to assess the feasibility of performing the study within the environment.
In order for your protocol to be expedited, you must indicate that the protocol is a JIT or a peer-reviewed and funded grant application on your “Protocol Review Form” (include the NIH (or other) grant number), or you must otherwise justify a request for expedited review.
- Exempt reviews are designed for secondary data analysis of non-MCC secondary data analysis such as SEER or Medicare data. These studies will be identified as exempt from full CPC subcommittee review by the CPC subcommittee coordinator and the CPC subcommittee chair at the time of initial submission.
Approval letters will be sent electronically to the PI after the protocol is approved. Once you get your approval, include a copy with your VCU IRB application. An original of your approval letter will be kept in the MCC Office of Clinical Research by the PRMC Cancer Prevention and Control Coordinator.
Advertisement or Mass Communication
If an advertisement or mass communication is planned for your study, please contact Ms. Jenny Owen in the Massey Cancer Center's Public Relations and Communications Office prior to submission to the IRB at: firstname.lastname@example.org.
Please plan to allow at least two weeks for review and approval of an advertisement or mass communication.
The items to be reviewed would include items such as the following:
- Recruitment letters
- Newspaper advertisements
- Radio announcements
- Public service announcements
All research projects that involve human subjects require IRB approval. The IRB submission requirements, submission guidelines and necessary forms can be accessed here.
If the project involves HIPAA protected data, a HIPAA waiver will be required. More information about HIPPA.
Exempt IRB Review
If the research qualifies for exempt review, according to IRB guidelines on review types, then both the PRMC and IRB reviews may be conducted by the same person. In order for the IRB office staff to properly route the study for review, check the box beside “This study involves cancer patients or is a Massey Cancer Center study”. Please note, that while a study may be exempt from consent, it may still require a PRMC scientific review if it has not been peer-reviewed through another mechanism.
It is required that physicians and research nurses be informed of all research projects that involve patient contact. There are several forums available for investigators to communicate to physicians and nurses. These include the following:
- Present the study at the weekly fellows meeting.
- Present and discuss at the weekly research nurses meeting.
- If the study involves patients likely to be discussed at a a multi-disciplinary clinic, the PI may schedule a brief presentation at the multi-disciplinary clinic to obtain the consent of the attending physicians.
- The investigator may also write a letter to each physician who has patients potentially eligible for the study.
- In addition, the investigator is required to request physician consent to contact patients.
It is preferable to send a letter to patients informing them about the study and that you will be contacting them either by telephone or in person to discuss the study further. This letter should be signed by the PI and the treating physician if that is agreed upon. Two options are available for obtaining physician consent:
- Obtain a blanket consent from all relevant physicians to contact all patients, and provide a list of patients contacted at an agreed upon schedule;
- Obtain an agreement in principle concerning participation of patients, and provide a list of patients to physicians prior to contacting them. Physicians will then strike from the list patients who should not be contacted along with the reason for non-contact. Consent would then be implied to contact those patients whose names were not stricken from the list. This could be done at agreed upon time tables.
Within any given study, a mixed method approach may be used (i.e., some physicians may provide blanket consent while others will consent on a case-by-case basis).
Once the PI has obtained approval to begin recruitment for the study, potentially eligible patients can be identified for contact through liaison with cancer center staff, both clinical and administrative, by directly examining the electronic medical record (CERNER) or scheduling system (IDX), use of the Clinical Trials Eligibility Database (CTED), or other means, as appropriate.
The CTED is an innovative tool for use by clinical research staff in pre-screening scheduled patients for eligibility in clinical trials. CTED explanation
CTED queries to search for patients based on a wide variety and combination of variables including: clinic, physician, diagnosis, age, race, sex, or visit type can be arranged through the CRIS core. For information on how to access CTED data, and training in using the database, members can contact Dr. Lynne Penberthy, or Mr. Dolan Smith (628-1877). Additional details about CTED.
If you amend an approved protocol you need to submit a copy of the IRB amendment form to the PRMC CPC subcommittee coordinator. Include summary of changes or redlined version, the revised document and, once received, the IRB approval letter. Amendments will not be scientifically reviewed by the PRMC; however, they will be reviewed for patient competition at MCC by the CPC and the PRMC parent committee. Examples of studies that will be reviewed include cases where an investigator changes the target sample population or reduces the sample number significantly thus altering the statistcal power.
It is possible that two or more research projects will recruit subjects diagnosed with the same cancer. Under these circumstances, it is the responsibility of all investigators to work together to avoid undue burden for patients. Investigators can choose to divide subjects so that each subject is offered the opportunity to participate in one study or investigators can pool their subjects and offer them the choice between studies, or the opportunity to participate in more than one study. The procedures will be study specific. It is the investigators’ responsibility to ensure that study managers are working together across studies to avoid the duplication of efforts.
Amendments that change the target population must include a memo detailing physician support and a competition plan that explains how conflicts will be resolved. If an amendment that does change target populations is submitted without such plan, the investigator will be notified by the CPC subcommittee coordinator that a plan is required. Once the plan is submitted the amendment will proceed through the system.
There are four forms of data that can be accessed to assist MCC investigators.
- The Massey Data and Analysis system
- Tissue acquisition data
- Cancer Cases and related information
- Electronic Medical Records and Scheduling
Massey Data and Analysis System (MDAS)
- Data Available Through MDAS
MDAS is a comprehensive, patient-centered, integrated data system that supports cancer data and analytic needs across the cancer center. MDAS is a repository of data for patients who have ever been seen within VCUHS with a cancer or major hematologic disease or by any oncology or palliative care specialist, as well as all patients who have died during inpatient admissions. MDAS includes all encounters for these patients – not just those related to oncology care.
Data are incorporated in MDAS from multiple sources across the VCU Health System including detailed hospital, physician and pharmacy billing data, cancer registry data, bone marrow transplant data and scheduled visits data. These data sources are integrated at the patient level to allow for retrospective analyses of patients, treatments, cost-effectiveness and outcomes.
In addition, external data sources such as US Census, SEER cancer incidence data, Behavioral Risk Factor Surveillance System (BRFSS) data and national death data are available here.
- Services Available for Using the MDAS
The Analytic Services team consults with and provides data to VCU Massey Cancer Center research members and their research teams who seek information about Massey’s patients and their treatments, or characteristics of the population areas served by Massey. The team provides information about available data and can advise about how the data may be used to answer specific research or business questions. Experienced analysts are available to consult and/or provide data at any phase of study exploration or development.
Prepared reports of patient volumes by cancer type and demographic characteristics may be valuable during grant exploration and submissions to justify patient volumes for particular focus areas. These patients volumes are used to determine feasibility of both clinical and CPC research. Other output may include custom data reports, analytic findings and interpretation or custom-created analysis datasets for further research.
Specific services that are available include:
- Consultation about data- possible uses and limitations/strengths.
- Consultation for data collection activities and develop custom databases or applications to allow for proper capture and central storage of data (to enable analyses and to allow efficient linkage with other data).
- Patient volumes to support clinical trials & observational research.
- Creation of patient lists to be used for chart review-based studies or quality review activities.
- Creation of custom datasets to be used for research projects.
Tissue Acquisition Data
The TDAAC provides tissue acquisition and analysis services. TDAAC personnel can provide informed consent services as part of the tissue acquisition. The TDAAC collects residual tissue and, for IRB approved studies, dedicated biopsy specimens of tissue for research at VCU. See TDAAC website for details as to services, contact information and available tissue.
Cancer Cases and Related Information
VCUHS maintains data on all incident cancer cases for VCU since 1985. Since October 2006, a new system for capturing information related to cancer cases was implemented. The automated interface is called ACE and captures and links all messages from pathology, radiology, discharge summaries, operative notes, as well as all inpatient and outpatient billing data at the patient level. Further, all tumor markers for these patients and other selected clinical laboratory test results are captured and linked. These source data are abstracted into a registry, but maintained and linked longitudinally to provide follow up information on all cancer patients over time to monitor recurrence, additional treatment and survival. The data from the registry and ACE can be obtained for IRB and PRMC approved studies. These data can be linked to tissue information or primary data as described above. For access to the registry or ACE data, requests may be made to the VCUHS Cancer Registry (628-2623).
Electronic Medical Records and Scheduling
In addition to the linked data systems that compose the CRIS Core at Massey, investigators may directly access either the patient scheduling system (IDX) or the Electronic Medical Record (Cerner) to capture data necessary for their study. For IRB and PRMC CPC subcommittee approved studies, access to Cerner and IDX can be obtained through application for a VPN key to hospital data and through training on how to access these systems.
PROGRESS REPORTS AND OTHER REQUIRED COMMUNICATION WITH PRMC CPC SUBCOMMITTEE
Studies are monitored by the PRMC CPC Subcommittee for accrual on a quarterly basis. The PRMC CPC Subcommittee coordinator will either send out an accrual monitoring form for you to fill out, or the investigator can log into ONCORE the MCC Clinical Trials Management system to report subject accrual and demographics. This will be reviewed at the quarterly PRMC CPC Subcommittee meeting.
You will also have to submit annual continuations to the MCC PRMC CPC subcommittee prior to sending your annual continuations to the IRB. There is no formal form; simply complete the IRB continuation paperwork and submit it to thePRMC CPC Coordinator at the same time that you submit your IRB continuation. Note: it does not matter if your study is EXPEDITED or FULL review through the IRB. ALL continuations must go through the PRMC full review process. The only ones that are exempt are those that are EXEMPT through PRMC.
The date when a study opens to accrual, continuing reviews, and suspensions/ or holds should be reported to PRMC CPC subcommittee coordinator.
Studies closed to accrual or closed by the IRB should also be reported to the PRMC.
If your study experiences any adverse events you must copy your IRB report of this event to the PRMC CPC subcommittee coordinator.
Outside investigators (i.e., non-MCC members), who will recruit MCC patients must identify a member of the MCC faculty with whom to collaborate. The MCC faculty member will be responsible for ensuring non-duplication of efforts within MCC, optimal scholarship of the research, and may serve as the liaison for data access.