Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Human Subject Research:Proper Record Keeping and Data Management Practices,Research Seminar Series,March 28,2003,9:00-10:30 a.m.,Objectives,Why is record management important?,What is CWRU policy on data custody?,How does this policy affect human subject research record management decisions?,What resources are available to assist with human subject research data management?,Why is Record Management Important?,Integrity of research,Intellectual property protection,Ensuring confidentiality,Compliance with sponsors requirements,Data Management and Research Integrity,Research data,including detailed experimental protocols,all primary data,and procedures of reduction and analysis are the essential components of scientific progress(NIH),Integrity requires meticulous attention to the acquisition and maintenance of research data(NIH),Questions about the integrity of the research are often answered by inspecting and reanalyzing the primary data,If the veracity of published results are challenged,data can be subject to subpoena,Data Management and Intellectual Property,Research data are legal documents for purposes of establishing patent rights(NIH),Legal challenges to inventorship often require producing the,original,data with recorded dates,Proprietary issues can also drive data access and sharing practices,Data Management and Confidentiality,Sponsors and/or the university may want data to be kept confidential for proprietary or security reasons,Regulations to protect human subjects may require data to be kept confidential,Confidentiality concerns will dictate how data is collected,retained and shared,Data Management and Sponsor Requirements,Requirements can include:,How long data should be kept,With whom data can be shared,Who has rights to the data,CWRU Data Custody Policy,Research data are defined as the material,originally recorded by or for the investigator,commonly accepted in the scientific community as necessary to validate research findings,CWRU Data Custody Policy,Principal Investigator(PI)Responsibilities,The PI is responsible for maintenance and retention of research data in accord with this policy.,The PI should adopt an orderly system of data organization and should communicate the chosen system to all members of a research group and to the appropriate administrative personnel,where applicable.,CWRU Data Custody Policy,Data Sharing,In group research projects,the PI is obligated to give co-investigators access to the research data or copies thereof for review and/or use in follow-on research,with proper acknowledgement.,Where applicable,appropriate measures to protect confidential information must be taken.,Data Management Issues in Collaborative Science,It is important to set the ground rules early in collaborations with regard to:,access to data(when,to what level,cost),authorship issues,transfer of data,materials,confidentiality provisions,pre-existing obligations to sponsor(s),CWRU Data Custody Policy,Retention,Research data must be archived for not less than three years after the final close-out or publication,whichever occurs last,with original data retained whenever possible.,CWRU Data Custody Policy,Data Transfer,When individuals involved in research projects who are not PIs at CWRU leave the university,they may take copies of research data for projects on which they have worked.The PI must,however,retain original data at CWRU.,If PI leaves CWRU,and a project is to be moved to another institution,custody of the data may be transferred with the approval of the Vice President for Research and Technology Management.,CWRU Resources for Data Management,Policies and Guidelines(e.g.,Data Custody,IP,Authorship,Human Subjects),Sponsored Projects Administration and Compliance Offices,Andrews Records Management Agreement,Andrews Records Management,Can be used to store all types of“paper-based records,OSPA will cover one-time charges associated with sponsored project records(e.g.,initial pick-up,delivery,shelving,destruction),Department/School responsible for on-going storage charges($.20 per cubic foot per month),Contact Jerry Takacs at 800-260-7556 to get started,Records Management for Human Subjects Research Records,What do I have to keep?,In what format do I have to keep it?,How long do I have to keep it?,How do I destroy records?,What is a“record?,“Any document,device or item,regardless of physical form or characteristic,which is created or received by any UHC office,department,or clinical area,and which serves to document the activities,organization,functions,policies and procedures,decisions or other activities of UHC and its staff.,University Hospitals of Clevelands definition in Administrative Policies and Procedures II 3.12,Types of Human Subjects Research Records,Research Records,Examples include but not limited to medical chart(research record)and information,questionnaires,audi