Cancer Registry Data Request - Kaiser Permanente



GENERAL GUIDELINES OverviewRequests for use of Kaiser Permanente (KP) Implant Registries data for the purposes of research must be submitted on the KP Implant Registries Research Request Form by the KP physician or employee responsible for such use of the data. KP Implant Registries data may only be used for the research purposes described on the form. Use of KP Implant Registries data in a manner for which they have not been approved can result in IRB and HIPAA violations and state or federal sanctions against Kaiser Permanente, as well as the barring of the researchers involved from further research with the KP Implant Registries.KP Implant Registries review procedure, requirements, and timelineRequests for research studies, presentations, publications, and pilot studies go through a review process prior to approval. The process includes several steps.Project design: This step is REQUIRED. The interested investigator arranges a telephone meeting with a member of the KP Implant Registries analytical team to discuss his/her idea. The meeting will help inform both parties as to what is feasible, what has already been done, what is likely to be supported by the registries, and who may already have expressed interest in the topic. The analyst will also make clear what is required and go over the request form and guidelines. To schedule a meeting, please email: heather.prentice@Institutional Review Board (IRB): This step is REQUIRED. The KP Implant Registries office has an active IRB-approved application for each of its registries. If the investigator is interested in a topic that falls outside the scope of the actively approved application, the project manager for the given registry will work with the investigator to submit the necessary documentation to the IRB. Aside from the IRB application, all investigators are required to complete Research Compliance Training. The investigator is required to submit documentation of completed compliance training to the KP Implant Registries office. Refer to your Region’s research website for compliance training requirements. Requirements typically include:HIPAA training certificateSOP-502 certificateProtecting Human Research Participants training certificateSigned Conflict of InterestCollaboration: The KP Implant Registries office encourages collaboration among clinical investigators. In particular, if the investigator is new to registry-based research, the KP Implant Registries office will require a more experienced investigator be included to help direct the research project. Investigators interested in a similar topic may be recommended to collaborate on one project.External Parties: Additional documentation is REQUIRED if outside external parties are involved as collaborators (e.g., universities or other institutions). The investigator will need to provide the KP Implant Registries office with a copy of the appropriate Business Agreement, Data Use Agreement, Confidentiality Agreement, and/or Raptor Approval Form. Documentation of completed Research Compliance Training through the collaborating institution is also required for every external investigator. Refer to your Region’s research website for forms and requirements. The KP Implant Registries only shares summary level data with external parties, patient level data is not shared. In projects involving data sharing and external collaborations, the KP site Principal Investigator is responsible for:The design, oversight of study execution, analysis, and manuscript preparation for the studyIRB and HIPAA complianceFinancial oversight for the project, if outside funding is obtainedEnsuring the appropriate documents have been executed (e.g., subcontracts, data use agreements, confidentiality agreements)Review: The next step is for the investigator (Requestor) to submit a completed “KP Implant Registries Research Request Form” to the KP Implant Registries office. This will begin a formal feasibility and methodological assessment by the analytical team.Feedback will be provided to the Requestor within two weeks. If changes or further information refinement is required, the Requestor will be asked to refine and resubmit the request. Multiple iterations are common.Proposals that are accepted are prioritized by the KP Implant Registries analytical team and placed into a queue based on the size of the project and the availability of staff to perform the data analysis. Timeline: Once a proposal is accepted, a general timeline is prepared for the project starting from data collection and ending with manuscript submission. All involved parties will agree to the timeline. Failure to meet the timeline may adversely impact future data requests by the Requestor. Depending on queue placement and the extent of the proposal, timelines can vary greatly between studies. Allow a minimum of two months for preliminary data analysis.Authorship: Research presented or published using data from the KP Implant Registries shall use authorship criteria recommended in the International Committee of Medical Journal Editors guidelines on authorship (), which are recognized and recommended by almost all published journals. The KP Implant Registries office will assist in establishing roles, responsibilities, and authorship for individuals involved in the project. Once your analysis is complete, the KP Implant Registries office will continue to assist in presentation and manuscript preparation. Whenever possible, the surgeons of the Permanente Medical Groups, as well as the KP Implant Registries staff, should be acknowledged.Presentations and Publication: KP Implant Registries office will provide data analysis support, as well as the methods and results sections of a manuscript and tables and graphs necessary for publication or presentation of the data. All abstracts, presentations, and manuscripts must be reviewed and approved by the KP Implant Registries office prior to presentation and publication.The KP Implant Registries office does not base timelines on presentation or publication deadlines.The Requestor must inform the KP Implant Registries office prior to the submission of project results for presentation at symposia and conferences. The KP Implant Registries office does not provide financial support for the presentation of papers.The Requestor is responsible for performing a literature review, formulating all other sections required for the paper, and meeting the non-data collection and analysis timeline requirements. Once the manuscript is completed and reviewed, the KP Implant Registries office will assist with the basic formatting and submission of the paper for publication. The Requestor is responsible for working with the co-authors and formulating and submitting any revisions that are requested. The KP Implant Registries office will provide any additional data analysis, if requested.KP Implant Registries Research Request FormPART 1 - complete for all data requestsPlease complete ALL required sections of the KP Implant Registries Research Request Form, and submit to Heather Prentice (heather.prentice@, Fax: (858) 637 6758, Phone: (858) 637 6711). Applications will be reviewed upon completion of all sections.Name of All Requestor(s):Department(s):Affiliation(s):Role/Title(s):Primary Phone:Email(s):Registry Involvement: FORMCHECKBOX AAA Stents FORMCHECKBOX ACLR FORMCHECKBOX Cardiac Devices FORMCHECKBOX Heart Valve FORMCHECKBOX Hip Fracture FORMCHECKBOX Shoulder Arthroplasty FORMCHECKBOX Spine FORMCHECKBOX Total Joint ReplacementReason for Request FORMCHECKBOX This is a request for a Descriptive Report (no hypotheses are being tested), only descriptive information is being provided. If this is a descriptive report, please answer Part 1A only.NOTE: This is a request for aggregate-level data, inclusive of means, frequencies, proportions, and standard deviations only. No comparisons will be done between groups and no other statistical analysis will be provided (e.g., P values, confidence intervals, risk estimates). FORMCHECKBOX This is a request for an Analytic Study. This is a request to use information from registries to examine a specific hypothesis. If this is an analytic study, please answer Part 1B only.Who is the target audience? _____________________________________________________________Is this request for: FORMCHECKBOX Presentation FORMCHECKBOX Publication FORMCHECKBOX OtherTarget symposia/conference: ________________________________________________________Target journal: ____________________________________________________________________Other: __________________________________________________________________________Part 1A. Descriptive Report - only complete if this is NOT an analytical studyPlease provide detail on what you are trying to describe with the data provided. Include the population you want to review (please specify inclusion and exclusion criteria), when (years of interest), where (what regions, medical centers, etc), and any other important information regarding the question you are trying to answer. What is the importance/clinical relevance of this study to KP? How will findings from this study be used to improve the quality of patient care?Please identify the specific data elements you are interested in reviewing in your report and provide any reference supporting the relevance of that data point. E.g., year of surgery, gender, race, medications (specify), types of procedure (specify ICD-9/ICD-10 or CPT code, if applicable).In what form would you like the data? Raw numbers, rates, means, standard deviations, maximum, minimum, ranges, etc?In what format are they to be presented? Would you like this in an excel sheet, tables, summary text, graphs? Part 1B. Analytic StudyNOTE: We recommend using the STROBE guidelines for reporting (). Please review before submitting the request as they are helpful in the planning of your upcoming study.Please summarize the most current literature (whenever possible, articles since 2000 are suggested) on the study topic. This should consist of two paragraphs. Include a list of references. Paragraph 1: What is currently known on the topic? Paragraph 2: What are some of the gaps in the literature that the proposed study may be able to address? What is the importance/clinical relevance of this study to KP? How will study findings be used to improve the quality of patient care?State the study objective as precisely as possible. State the research question. Research questions must be specific, including: who you are studying, the specific intervention/exposure and outcome of interest, and what/who you are comparing. Simplicity is recommended. Consider using the PICO format: What is the Patient, population, or problem? What is the Intervention/exposure of interest? What is the Comparison to your intervention/exposure? What is the Outcome of interest? State the research hypothesis. State your research hypothesis as a statement with a tentative answer to your research question. Include the expected relationship between the intervention/exposure and the outcome. E.g., the exposure increases risk of the outcome. No more than two hypotheses per request.List inclusion criteria for the sample to be used in your study. Please include detail on exactly what you want to focus on, what to exclude, and reasons why. Include years of interest, regions, demographics, diagnosis, types of procedures, types of surgical approaches, specific subgroup of patients, special considerations, etc.Define the intervention/exposure of interest, be as specific as possible. This is the actual characteristic, treatment, or risk factor that you are interested in finding out whether there is an association/relationship with the outcome that you are studying. E.g., metal on metal bearing surfaces, graft used in ACLR, age greater than 90.Define your outcome of interest, be as specific as possible. This is the actual event that you are interested in finding out whether there is an association/relationship with the intervention/exposure that you are studying. We recommend one outcome (or two maximum) per request. If more than two are listed, please specify the reason why this cannot be completed as a separate study. If appropriate, include the timing of the outcome that you are interested (e.g., death within 30 days, revision at the longest follow-up time available). Based on your review of the literature, list variables that are or may be related to the outcome and exposure/intervention you are studying. These are the possible confounders. Most studies include age, gender, and other patient characteristics. However, if there are other important variables that could impact the outcome/exposure relationship you are studying please list here so they can also be investigated in the analysis. Part 2 - Acknowledgements by the Requestor(s)Upon approval of the research request, the Requestor(s) will provide the KP Implant Registries office with all documentation of completed IRB compliance training.If outside external parties are involved as collaborators (e.g., universities or other institutions), the Requestor(s) will provide the KP Implant Registries office with a Business Agreement, Data Use Agreement, Confidentiality Agreement, and/or Raptor Approval Form. The Requestor(s) is responsible for sending these documents to the KP Implant Registries office before access is given to any data. No other external party shall have access to the records where individuals may be identifiable.All reasonable efforts will be made to limit the use or disclosure of PHI to only that which is necessary to accomplish the intended purpose. If access to records is granted, the Requestor(s) agrees to abide by the provisions of the KP HIPAA and confidentiality policies, ensuring security and protection of identifiable record level data as follows: All PHI, or derivative files (i.e., de-identified data sets) will not be passed on to any other party without the express written consent of the IRB and approval by the KP Implant Registries office.Paper copies of records will be kept in locked cabinets in access-protected premises.If photocopied, identifiers will be obliterated completely.Access to computers and records stored in them will be restricted through use of passwords and other appropriate access control procedures.All study related electronic files will be transferred through secure electronic file transfer methods. All files, documents, or other records containing PHI or KP Implant Registries data will be destroyed no later than necessary to complete the work, but no longer than the end of the study; unless the KP Implant Registries office, in its sole discretion, extends the deadline for destruction after consideration. Destruction means physical destruction of files documents or other records. This means shredding/destruction of hard copies, permanent deletion of electronic files and recycles bins. All file copies on regular/manual back-up systems need to be permanently deleted. De-identification shall not be considered destruction.The information obtained from the KP Implant Registries will be used only for the research purposes outlined in the completed “KP Implant Registries Research Request Form”.The Requestor(s) bears all risks resulting from publication or presentation.The Requestor(s) certifies that the information reported in this form and the appended research project proposal is accurate and agrees to comply with the terms and conditions contained in this form.Name of Requestor(s): ___________________________________Title: ___________________________________Date: ___________________________________ ................
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