What happens at the end of my research project?

Study closure procedures in the School of Health Sciences

Guidance for Staff and PhD Students

Study closure is an important aspect of managing a research project and requires special attention. This document is a guide to study closure procedures and explains the infrastructure provided by the School to support good practice. The procedures apply to funded projects, unfunded projects and PhD projects, if they involve primary data collection or if they may result, or have resulted, in submission of a paper for publication. Masters students may also use these procedures if their project is likely to lead to further research activity, or if they require NRES/IRAS approval.

Why are closure procedures important?

In accordance with University guidelines, Ethics Committees require the secure storage of data for 10 years from the date of the project finishing. There are however further rules governing different types of data that must also be followed and these can be found in the “Retention of Documents” guidance.

Increasingly, funders require data to be made available to other researchers on request, for secondary data analysis. Researchers in other institutions may also request details of study methods and procedures, for example, when conducting systematic reviews of the literature. Thus, data should be retrievable while the identity of individuals who have provided the data should be protected; and study materials (e.g., measurement instruments and descriptions of procedure) should be stored in a way that facilitates access when required.

In addition, occasionally there are disputes about authorship rights, intellectual property rights or the proper conduct of a study. Appropriately stored and retrievable documentation (e.g., minutes of project meetings, funding applications, study protocols, data analysis documents, early drafts of papers for publication) can provide evidence to support the originality of the research and to demonstrate the research team’s intellectual ownership of the study outputs.

Finally, documentation of study impact over a number of years (e.g., for a REF-style assessment) requires a clear electronic audit trail back to the original research. These procedures and a storage infrastructure will assist research teams to document impact.

Who is responsible for study closure?

The Principal Investigator (PI) is responsible for implementing closure procedures. For student projects, the student has responsibility for study closure procedures and is thus the PI for the purpose of this document. A Project Archive Logto support closure is provided in Appendix 1. This records the Ethics Reference Number or SHS Project Reference Number, name of the PI, description of study documentation, location and document destroy date. Students should submit their completed checklist to their supervisors; staff should submit their completed checklist to the Research Centre Administrator (Verity Sullivan) who will forward it to the School Research Ethics Committee and to Research Centre Leads.

When is the right time to commence study closure procedures?

Funded projects: Within one month ofacceptance by the funder of the final report. Partial closure may be appropriate at this time, during writing of papers for publication. Final closure should occur within one month of the publication of the final paper from a research project.

Does all study documentation have the same destroy date?

No.

Documentation that includes personally identifying information (e.g., participants’ names, contact details, consent forms) should be destroyed on the final closure date. This involves dropping hardcopy files in a secure bin or confidential waste bag for secure disposal. Please do not use waste paper bins or open recycling bins for disposing of personally identifiable information. Audio-recordings, digital recordings and videos should also be destroyed on the final closure date (at the latest) providing paper and/or electronic transcripts are stored. Unless it is absolutely necessary to keep the recordings, they should be destroyed at the earliest opportunity, in order to avoid any breaches of confidentiality.

Data files (e.g., completed questionnaires, interview transcripts, intervention materials, summary data tables) and other study documentation (e.g., interim reports, final reports, minutes of key project meetings) should be archived using the procedures described below and held for 10 years (or longer, according to the requirements of the relevant ethics committee and/or funder). Please refer to “Retention of Documents” guidance (attached).

Procedure for archiving hardcopy data and documents

Please consider scanning paper documents to minimise the amount of space required to store data. To store hardcopy documentation:

  1. Please order archiving boxes from your Divisional Administrator
  2. Fill the boxes with the paper materials.
  3. More than one type of document can be placed in a box butwhere possible, it is helpful to keep project documents with similar destruction dates together
  4. Use the Project Archive Log (Appendix 1) to note which documents are stored in each box
  5. Print one copy of the log for each box and place on the external side
  6. If you are using more than one box, please number the boxes (1/3, 2/3, 3/3 etc)
  7. Please notify your Divisional Administrator whenthe boxes are ready for archiving.

The boxes will be stored in a secure locked store room within Myddelton Street until capacity is reached. Only up to two named custodians approved by the Ethics Committee will have access in or out of the room, so it will be secure. The room does not have space for filing cabinets so all documents must be boxed before sending. If we reach capacity in the store room staff will be notified to identify which documentation can be securely stored with an external storage company. This will not happen without PI consent.

As the University is advising its staff and students to retain study data and documentation, the University will also need to provide the mechanisms to do so and to be clear about how and where documentation should be stored. Additional advice may therefore be provided by the University and this advice will be integrated into future versions of this document.

Procedure for retrieving hardcopy data and documents

To retrieve your archived box please email your saved completed copy of the Project Archive Log (Appendix 1) to Verity Sullivan and indicate which box number you wish to have. Boxes will be returned to you no later than one full working day from your request.

Procedure for archiving electronic data and documents

To store electronic files:

Saveddata, descriptions of methods (procedures and materials), meeting notes and draft papers should be saved in a folder which has been created on the Z drive. Folders should belabelled with the name of the study / PI / destroy date (DD) and a clear sub-folder structure with appropriate names,for example:

  • Folder name: PI, Brief study name or acronym, document destroy date [DD], e.g., JSmith_ICARUS_DD01012019
  • Sub-folders
  • Archive details (copy of Project Archive Log; Ethics approval documentation; final study report)
  • Data files
  • Methods (e.g., study protocol, information sheets, materials)
  • Results tables
  • Meetings (i.e., project management, including minutes of research team meetings)
  • Drafts of papers for publication

When these files are ready, please contact IT with a request to archive the files. Please write the pathway for accessing the archived files on the (paper) Project Archive Log. Any identifiable electronic data must be encrypted.

Procedure for storing publications arising from the study

Publications should be stored on City Research Online (CRO) as this is the most accessible form of long-term storage of publications.

Procedure for storing data files with a view to making them available for secondary analysis

Some funders require that the data files from a funded study be made available to external bodies and/or academics who wish to verify published analyses or to explore the data further. Hence, the Project Archive Log (Appendix 1) includes the name of the Custodian of the Data (usually the PI or nominated delegate), who would be the contact person for these types of enquiries. In this situation, the “Publications” file listing all results papers based on the study data set is particularly important. This is to avoid unintentional duplicate publications.

Please note

After the date of final study closure (i.e., after all papers from the project have been published), staff can rely on the School’s archiving processes to access documentation if needed, and can remove study documentation from their filing cabinets or shelves in offices or in open plan storage areas, confident that documents can be retrieved if required. This should enable us to use the physical space efficiently and without clutter. If possible, please use electronic files for your own records and ensure secure storage of all paper-basedstudy documentation.

APPENDIX 1: Project Archive Log

APPENDIX 2: Final Report Template

1

School of Health Sciences (SHS) Study Closure Procedures Version 2February 2017

APPENDIX 1: PROJECT ARCHIVE LOG

Ethics Reference Number
(or SHS Project RefNo) / Box Number
Staff Name (PI) / Custodian of Data / Student or Supervisor Name
Project Title
Start Date / Est. Study Closure Date / Final Closure Date
Documentation Archived
A - Recruitment materialsD - Intervention materials
B - Ethics / governance documentsE - Questionnaire templates /
C - Transcripts/completed questionnaire / interview topic guides
other dataF - Study closure report (for NRES)
G -Other (please describe)
/ Box 1:ABCDEFG
Box 2:A B C D E F G
Box 3:A B C D E F G
Box 4: A B C D E F G
Funder / Date of final payment from Funder / Final report sent to funder
Yes No
Dates of publication(s)
Location of Study
Documentation / Paper
Electronic
Destroy date / End of (month) ………………….
Year……………….. / Signature of Student / PI
Date
Next steps:
Students to submit this form to their Supervisor Staff to submit this form to their Research Centre Administrator (Verity Sullivan)

1

School of Health Sciences (SHS) Study Closure Procedures Version 2February 2017

APPENDIX 2: PLAIN LANGUAGE SUMMARY OF FINAL REPORT (suggested maximum length2 pages)

Study Identification Number
Project Title
Investigators
Brief Abstract
Rationale
Methods
Results
Conclusions
Publications arising from project
Other impact or expected impact
Any ethical issues raised /
addressed

1

School of Health Sciences (SHS) Study Closure Procedures Version 2February 2017