The data generated for this project are being recorded in Word and Excel files
which are proprietary but widely used and easily convertible to rtf/csv if
needed. This means that the data are easily able to be opened and used by
others without the need for specialist software.

There is no agreed standard for recording data and metadata in this area of
research but the researchers will follow the processes outlined in this plan
to ensure that it is as easy for others to understand it as possible. The
metadata at a dataset level made available via Pure and/or Datacite via the
DOI is searchable and standardised and so should facilitate automated
searching and assessment although not automated combining of the underlying
data.

Where researchers utilise shorthand vocabulary to describe data for example in
file names, protocols or columns headings these will be described in the excel
spreadsheet or linked to from the spreadsheet and held with the project files.
This should enable others to understand the work that has been undertaken.

**2.3. Making data interoperable**

#  2.4. Increase data re-use (through clarifying licences)

As it is likely that data will be subject to extreme confidentiality
restrictions, it is not possible to specify any licences for data sharing at
this stage. This plan will be updated with further detail should it be
possible to make any dataset available. The Pure system currently include
Creative Commons and Public Data Commons Licences as standard and USTRATH has
the option to expand these classifications if a more appropriate licence was
identified for a dataset.

Data are subject to a 4 year on-disclosure agreement but wherever this if
found not to apply data will be shared upon completion of the dataset. At the
expiration of the non-disclosure agreement any data that can be shared will be
made available and the only foreseeable impediment to this sharing is
commercialisation.

The current practice at USTRATH is to retain data for 10 years unless there is
a stipulation not to for legal reasons. At the review point the researchers
will be consulted and the statistics related to data access considered before
a decision is taken about whether to retain or destroy the data.

Data created are sampled and spot checked by the supervisor of the students
using the spreadsheet record as the starting point. This ensures that systems
proscribed are being followed.

**3\. Allocation of resources**

#  Data security

What provisions are in place for data security (including data recovery as
well as secure storage and transfer of sensitive data)?

Is the data safely stored in certified repositories for long term preservation
and curation?  
  
<table>  
<tr>  
<th>

Data generated by the project will be stored at GSK and at USTRATH.

At USTRATH: During research data will be stored on Dropbox and backed-up on
Strathcloud in folders accessible only to the student and their supervisor.
Strathcloud sits upon USTRATH’s storage which is dual sited and replicated
between two data centres which are physically separated by several hundred
metres. Data links between datacentres are provided by dual disparate fabrics,
providing added resilience. Additionally, the central I.T. service provides
tape based backup to a third and fourth site. Completed data will be deposited
in USTRATH’s Pure system which is also based on the storage detailed above.
Data can be recovered via

Strathcloud or Pure at the system level or by using the replication/back up
options if needed.

</th> </tr>  
<tr>  
<td>

Data retention processes for Pure have been detailed in an earlier section of
this DMP. The costs related to research data management & FAIR fall into three
categories:

At GSK: GSK Vaccines has validated systems and SOPs to ensure that data are
collected, The opportunity cost of time taken by researchers during research
to record and

1\.

processed, transmitted and archived in a way that guarantees data
confidentiality and annotate the outputs of their research effectively: this
is good practice and excellent

integrity and applies industry standards when available (e.g. CDISC). These
systems and training for our students’ future careers.

processes are regularly audited by GSK Vaccines Quality department and have
successfully Costs for data storage during and beyond the project: data will
be stored in various

2\.

undergone a significant number of inspections by EMEA, FDA, PMDA and other
national areas & systems on the USTRATH infrastructure which is a robust and
resilient storage

authorities.

network designed to meet the needs of our researchers throughout the research

Should transfer of data between sites be required at any point, Strathcloud
will be used to lifecycle. This commitment by USTRATH is made as part of our
commitment to enable the transfer as it facilitates encrypted transfer of
files. excellence in research with the knowledge that costs are only partially
recuperated

</td> </tr>  
<tr>  
<td>

via FEC.

3\. Costs for data preparation and curation: the cost of supporting
researchers in data management planning, mediated data deposit and maintenance
of files over time is again undertaken by USTRATH as part of its commitment to
excellence in research.

Quantifying these costs numerically in relation to one project is not
feasible.

</td> </tr> </table>

#  Ethical aspects

Are there any ethical or legal issues that can have an impact on data sharing?
These can also be discussed in the context of the ethics review. If relevant,
include references to ethics deliverables and ethics chapter in the
Description of the Action (DoA).

Is informed consent for data sharing and long term preservation included in
questionnaires dealing with personal data?

There is a legally binding non-disclosure agreement in place that restricts
the project’s ability to make data openly available as discussed earlier in
the plan.

Ethical approval has been obtained by both sites as this is relevant to the
data that the project will use. The Ethics approval documents are stored with
the data and will be used to direct the research in conjunction with this data
management plan.