Data Management And Access Plan
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Section 1 - Research Details
Contracting Organisation:
Oxford University Hospitals NHS Foundation Trust
NIHR Study ID:
NIHR207903
Research Title:
Tailored physiotherapy rehabilitation after revision total hip replacement: a feasibility randomised controlled trial
Trial Registration:
ISRCTN Registry - ISRCTN10649335
Research Type:
Pilot/Feasibility study (stand-alone)
Section 2 - Contact Information
Chief Investigator:
Erin Hannink (0000-0002-1422-4625)
Chief Investigator:
Karen Barker (0000-0001-9363-0383)
Additional Organisation Contacts:
Relevant institutional, departmental or study policies on data sharing and security:
Section 3 - Data Collection
Study Settings:
NHS hospitals in England
Study Outcomes:
| Type of Data | Data Area | Data Type | Other |
|---|---|---|---|
| Clinical measurements | Comet - Life impact | Physical functioning Emotional functioning/wellbeing Global quality of life Perceived health status | |
| Qualitative | Comet - Life impact | Delivery of care | |
| Qualitative | Comet - Resource use | Economic Hospital Need for further intervention Societal/carer burden | |
| Qualitative | Comet - Adverse events | Adverse events/effects |
Section 4 - Data Description and Collection, or Re-Use of Existing Data
Q4a. Data to be Collected/Produced:
New data will be collected through case report forms and participant resource use diaries. Data will be pseudonymised using a patient ID. Data will be entered onto a REDCap database where data provenance will be documented. Qualitative interviews will be transcribed, de-identified and pseudonymised. There has not been re-use of existing data.
Q4b. Format of Data Collected/Produced:
Case report forms (CRF) will contain data that will be a mix of numeric and textual. They will be collected on pdf or doc, then entered onto a REDCap database. Data format will vary based on administration methods at different trial sites and according to patient preference. If a research clinician or participant prefers to complete CRF or questionnaire on paper, the paper will be scanned into pdf. If the CRF is completed as a doc template, it will be saved as a doc. Once data are entered onto REDCap, it can be converted to csv.
Qualitative interview data from both participant and physiotherapist interviews will be collected on an encrypted audio recorder by the central study team. Following transcription, the audio recording held by the researcher will be deleted. The transcription will be stored as a doc file.
Section 5 - Data Quality Control
When reporting clinical measures, all physical outcome measures are standardised tests. Research clinicians will receive training and written instructions on how to conduct the clinical measures and multiple trials will be completed.
Our REDCap database is set up for data entry validation. A portion of the data entry will be peer reviewed by another member of the research team. Data quality and completeness will be reviewed by the Trial Steering Committee.
Routine central monitoring of data will include review of critical data points, checks for missing data, data queries, outstanding CRFs.
Section 6 - Storage and Backup During the Research Process
Q6a. During Research Data Storage:
Data will be stored on secure Oxford University Hospitals NHS Foundation Trust servers that are backed up regularly.
Q6b. During Research Data Security:
Data will only be accessed by Oxford University Hospital (OUH) members of the research team. Collaborators outside of OUH will not have access. Data containing personal information will be stored on the secure OUH server and the file will be encrypted.
Section 7 - Data Sharing and Long-term Preservation
Q7a. Data Sharing Availability/Suitability:
The quantitative data, and anonymised transcripts of qualitative interviews, will be retained for five years on the OUH secure server. Contact details will be deleted when no longer required as part of the study (following posting of the summary of study results). This will be within 12 months of the end of the study.
The data sharing plans for the current study are unknown and will be made available at a later date.
Q7b. Location of Available Data:
At this point in time there is no prospective data sharing planned due to the small number of participants in the study. However, access to the data for purposes of research other than this study would be at the discretion of the CI and in accordance with the terms of patient consent.
Q7c. Access Requirements for Available Data:
Data sharing requests will be handled directly with the requestor.
Section 8 - Data Management Responsibilities and Resources
Data Responsibilities:
Site Principal Investigators will be responsible for capture of source data and archiving of their Investigator Site File. The CI and Trial Manager (OUH) will be responsible for central data management (data entry into database, data quality monitoring, storage and back up, archiving of the database/TMF and data sharing). The trial manager will review the DMP.
Data Resources:
Trial manager time to cover data management, and Statistician time to support data cleaning and analysis, are fully costed within the research grant. No additional repository fees are anticipated.