Project Data Management Plan MCRI's Data Management Coordinator is very keen to receive feedback on the content of the template, including ideas for new sections or for how the guidance might be improved. 1. This Data Management Plan Document Brief details of this plan document Project Title Plan Version Plan Date Plan Author Related Documents Specify file name and location of, for example: Current version of study protocol Current Project Management Master Checklist Version (CCCH) File Name: Plan Version: Plan Version Date: Plan Author: Template: MCRI_Project_Data_Management_Plan_Template_1.01_2013-05-05.docx Page 1 of 10 2. Data Management Plan Scope What data is this plan covering? What existing data will you use, and what data will your project create or acquire from an external source? Existing Data Local resource: RCH/MCRI repository/databank, research project (include Ethics database registration number, if one exists) External resource: RCH/MCRI repository/databank, research project Data to be Created Summarise data sources and collection instruments Questionnaires (paper/electronic) Assessments (paper/electronic) Standard measures Multimedia files Externally sourced data e.g. lab results Tracking data e.g. recruitment, follow-up, specimen storage Result sets Other Materials State any other documents or materials that will be associated with the project data Code book File Name: Plan Version: Plan Version Date: Plan Author: Template: MCRI_Project_Data_Management_Plan_Template_1.01_2013-05-05.docx Page 2 of 10 3. Ownership of Data and Intellectual Property What is the ownership of the project’s IP? Are any additional requirements specified by owners of externally sourced data? IP Ownership for this Project Typically this will be MCRI (see the IP policy) Considerations for Data Sourced from Outside this Project Specify any boilerplate citation text or co-authorship credit. Are there signed agreements with other parties Are licences required e.g. for use of standard measures such as PedsQL File Name: Plan Version: Plan Version Date: Plan Author: Template: MCRI_Project_Data_Management_Plan_Template_1.01_2013-05-05.docx Page 3 of 10 4. Data Types What types of data are you collecting. Here “Type” has both a technical sense and also relates to the content of what you are collecting. Electronic File Formats What file format will be used for each item from section 2 that will utilise electronic files? Is it possible to use a “standard” or open format that does not require specific hardware or software in order to access it? Consider both Data files Documentation files 1. For examples of recommended formats see the UK Data Archive’s Guide to Managing and Sharing Data. A link is available from the Resources section of the Data Management Planning intranet page. Confidentiality and Privacy Does your project contain data in the following categories? What measures will you employ to protect the data? Informed consent for data storage and research use, confidentiality agreements. Personal information (data that could potentially be used to identify an individual) Sensitive information (data on a participant’s the racial or ethnic origin, religious, political or philosophical beliefs, sexual preferences, criminal record etc). Other culturally sensitive information File Name: Plan Version: Plan Version Date: Plan Author: Template: MCRI_Project_Data_Management_Plan_Template_1.01_2013-05-05.docx Page 4 of 10 5. Storage and Backup Obvious, but important, is considering where to store your data. Highest security, most restricted access is what you aim for, but consider your accessibility requirements: who needs access to what data and when? There will be different answers to these question for different data/document types/purposes. File Name: Plan Version: Plan Version Date: Plan Author: Template: MCRI_Project_Data_Management_Plan_Template_1.01_2013-05-05.docx Page 5 of 10 Storage of Non-Digital Data E.g. where will you store hard copies of paper questionnaire Storage of Electronic Files Consider the storage and accessibility of both Data files Documentation files Is a shared folder on a network file server sufficient? Does anyone require remote access via VPN or a web-based doc management system or database? Backup What is the backup regimen for the location(s) where digital data is stored? See details of MCRI/RCH file server backup regimens at https://www.mcri.edu.au/research/core-facilities/cebu/datamanagement/managing-data/backup/ Study Database What software package(s) will be used for processing and storing study data or for study management? Examples include: EpiData REDCap TeleForm Access File Name: Plan Version: Plan Version Date: Plan Author: Template: MCRI_Project_Data_Management_Plan_Template_1.01_2013-05-05.docx Page 6 of 10 6. Access and Security Think about how access to the different types of data listed in section 2 should be controlled What data should be restricted What data do you have that should have access restrictions placed on it? Personal, confidential or sensitive data Conditions of use for external data Who should have access to each type of restricted data Not necessarily individuals’ names, but access permissions by role in project Specific precautions taken to secure personal or sensitive data Specify the precautions taken to comply with your responsibilities for protecting such data e.g. maintain personal data in a separate database to questionnaire response data. File Name: Plan Version: Plan Version Date: Plan Author: Template: MCRI_Project_Data_Management_Plan_Template_1.01_2013-05-05.docx Page 7 of 10 7. Organisation and Metadata Consider and document how your project team will organise your electronic data and documents. Project network directory structure List your folders and state their function (if not obvious from the name!) File naming conventions E.g. a format that includes version numbering and/or date Document version control and managing collaborative writing How will document versions be labelled and controlled? Think about your data files and analysis/cleaning scripts as well as general project documents Metadata, metadata standards The metadata is the documentation of your project methods, data collection and data preparation as well as a comprehensive code book. Consider what you should document and how it can be made available. Can you use a standard metadata format e.g. DDI? Data file management procedures Consider and document how you plan to manage the data cleaning process from source data through to cleaned data files ready for analysis. File Name: Plan Version: Plan Version Date: Plan Author: Template: MCRI_Project_Data_Management_Plan_Template_1.01_2013-05-05.docx Page 8 of 10 8. Long Term Usage Plan for the long-term curation of your data. How will it be kept safe and secure after project completion? Can its value be increased by making it available to other researchers – and how will they find out about it? Responsibilities Describe the delegation of responsibilities amongst project team roles and/or members Alternatively, provide a reference to your Study Delegation Log document. Archival Guidelines are available from CRDO. Where will electronic and non-electronic data be stored long term? What are the retrieval implications (e.g. lead times, costs) Retention period For how long will be materials be stored? What should happen at the end of this period Re-use, Sharing Will data be made available to other researchers? Under what conditions? Discoverability – How will people know your project exists and how will they find out more? Project/metadata registration e.g. ethics office, ANDS File Name: Plan Version: Plan Version Date: Plan Author: Template: MCRI_Project_Data_Management_Plan_Template_1.01_2013-05-05.docx Page 9 of 10 9. Budget Impacts Do any of the items above have cost implications? Software licences Data storage capacity, backup charges Web hosting, SSL certificate Database development If so, how much and how frequently E.g. Group drive is “free” but may have per-project capacity limit. Extra MCRI storage is around 3 $/GB/year, invoiced by ITS to cost-centre. File Name: Plan Version: Plan Version Date: Plan Author: Template: MCRI_Project_Data_Management_Plan_Template_1.01_2013-05-05.docx Page 10 of 10