ࡱ> ruq B"bjbjh/h/ D@ Eg Eg>DD  8"!Tv!$ 0i!!(!!! # # #hhhhhhh$knh # # # # #h !!4h%%% #j ! !h% #h%%W^4d!0FLv#^`>hi00i`o#o|do d # #% # # # # #hh$ # # #0i # # # #o # # # # # # # # #DX : Guideline for Writing a Protocol Repositories (Data, Specimens, Registries) DO NOT USE this protocol template if you will be utilizing specimens or data from an already established repository. Use the  HYPERLINK "/sites/default/files/400-200%20Data%20Review%20Protocol%20Template.docx" Data Review Protocol Template. The format and information below is provided as a guideline to assist in writing a protocol (study design) for the creation and maintenance of databases, registries or repositories used for research purposes and should be completed as applicable to the type of repository being described. Study Title: Principal Investigator: Version Date: Purpose of the Study What are the general concept, scope and intended purpose of creating/maintaining this database/registry/repository (heretofore noted as repository)? The purpose of creating this patient registry is to organize surgical melanoma patient treatment data in a centralized repository, allowing for the research team to analyze various aspects of melanoma surgical and other melanoma care outcomes more efficiently. Background What is the justification and rationale for creation/maintenance of the repository? If relevant, provide information to understand why this repository is important and include any relevant literature citations. Description of the Repository Describe the operation of the repository, including the type(s) of research that the repository will support. In addition, the following information should be described here: What is the name and location of the repository for which consent is being solicited, to which subject is agreeing to provide specimens or data? How and by whom will the repository be maintained? Who will be responsible for assuring the quality of the information/samples in the repository? Who will have access to the repository? What are the conditions and requirements (if any) under which the data/specimens will be shared with recipient Investigators? How will the information be shared (i.e., identifiable or coded)? Will any research results from use of data/specimens in the repository be returned to the donor-subject? If so, when and how will incidental findings that might have health consequences for the individual subject be managed? How long will the repository be in place and will data/specimens be destroyed at any time point? Will subjects be able to withdraw participation from samples and/or data stored in the repository? If so, what is the process for doing so? What is the intended future use of information in the repository, if known (e.g., contacting individuals in the future, research purposes related to disease under study, research purposes related to other diseases)? If data/specimens may be used for future research that is not yet specifically identified, state that here. Also, indicate whether information may be shared with other institutions or transferred to other institutions. Will subjects be re-contacted regarding information in the repository? Will subjects be contacted in the future regarding use of data/specimens in the repository? If so, ensure the consent form adequately informs subjects of the intention for future contact and includes a statement to opt in to future contact. Please note that this is required for future testing that may be genetic in nature, according to the Policy on Research Involving Genetic Testing. This patient registry is intended to create a centralized patient repository of well-characterized patients with melanoma in southwest Michigan. This will be a registry that retrospectively reviews electronic health records of patients diagnosed and referred for surgical treatment of melanoma and melanoma in situ. Patients included in the study will have been treated at either Bronson Methodist Hospital. All eligible patients will be identified utilizing a specified query facilitated by the ͷ University Homer Stryker M.D. School of Medicine Virtual Data Warehouse (VDW). Data that can be extracted electronically will be included in the query. No clinical procedures, testing, or diagnostics will be required for the Registry participation. Registry staff will extract clinical data obtained as part of routine clinical care in the diagnosis and treatment of melanoma and melanoma in situ from 01/01/2017 12/31/2032. This data will be entered into a HIPAA compliant REDCap by the registry staff at regular intervals. All data will be retrospective. No subject interaction for the registry will be required. Study Population How many subject specimens/records will be included in the repository? Or, indicate if enrollment will be unlimited due to the nature of the proposed activity. What are the intended gender and age range of subjects included in the repository? What are the intended racial and ethnic distributions of the subjects included in the repository? Provide justification for any enrollment restrictions based upon race or ethnic origin. What are the criteria that define who will be eligible and who will not be eligible for inclusion in the repository (should support the purpose of the study)? Subject Identification and Recruitment How will subjects be identified and recruited for participation in the repository? Informed Consent How will consent be obtained (e.g., written consent, oral script, information letter)? Or, Provide justification for a waiver of consent / waiver of HIPAA authorization Risks and Benefits Risks: What are the potential risks of conducting this study (e.g., related to the collection of any biological samples or related to any potential breach of confidentiality related to the information being collected)? What protections will be put in place to prevent and/or minimize any potential risks? Benefits: What are the possible benefits from participation in the research? If there are no possible benefits, state no benefit. In most cases, contributing data/specimens to a repository, offers no benefit to subjects. Data Storage and Confidentiality How will data pertaining to the subjects participation be stored and who will have access to the data? How will the data be secured to maintain confidentiality of the data (e.g., coding data, using a secure data storage mechanism to prevent unauthorized access to the data, encryption of devices)? Will subject identifiers be collected (e.g., name, medical record number, date of birth, date of visit)? If so, specify if/when identifiers will be removed from the data set. REFERENCES Provide complete, numbered references for all citations listed in the order that they appear.     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