Skip to main content
Data sharing standard 1 - Length of Data Sharing Agreement

This standard is part of a series of guidance documents to support the various stages of a DARS application.

 

 

Standard description

Data sharing agreement (DSA) start data must ensure there is no gap from the end date of the previous agreement (where applicable).

The start date of the DSA can be prior to the date of approval by exception.

For new applications the DSA start date can not be in the past.

Data sharing agreement start date must not be more than 12 months in the future

Maximum agreement length from anticipated date of signature to agreement end date is:

  • archiving in relation to academic research purposes – up to five years1
  • commercial – up to 1 year
  • sub-licence – up to 1 year
  • anything else – up to 3 years

The DSA end date should take account of:

  1. The data being required for the period of the stated purpose(s).
  2. The end date of the agreement should not be longer than any fixed end date specified in any supporting material.
  3. The end date of the agreement should not exceed any specific end date in a s.251 approval (where appropriate).
  4. For clinical trials, medical files should be retained for at least five years (Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (section 18 and 28) or successive legislation).
  5. An end date beyond the period of analysis may be accepted if justified (as documented in the objectives section of the application) by one of the above reasons by a document of requirement of a funder or some other formal requirement, such as research council standard

Review period – three years

1 Subject to Article 89(1), 5(1)(e) and Recital 39 of the GDPR


Video

View a transcript of the Data Sharing Agreement length video.

Slide 1

Hello my name is Tracy and I work as a senior case officer in the Data Access request service team. 

Slide 2

This video is one of a series of presentations designed to help you use our Data Access Request Service (DARS) as effectively as possible.

You can view the other videos in this series on our Youtube channel at: www.youtube.com/user/HSCIC1

NHS Digital has published a number of standards in relation to how we assess applications for data from NHS Digital. These are designed to be transparent and to help you in completing the relevant section of your online application for data.

This presentation will provide detail on the agreed standard for completing the following section of the application: Length of a Data Sharing Agreement.

Slide 3

The Data Sharing Agreement or DSA is a contractual document between the Data Controller(s) and NHS Digital.  The agreement is established when the Data Controller has demonstrated that they have met the strict data governance standards by completing the DARS application process. If you follow the link you will find more information on the application process.

It sets out the period over which the Data Controller can hold and process data.

Data can only be held whilst your Data Sharing Agreement is in date. If you have an existing agreement, then there should be no gap from the end date of your previous agreement to the start of your new agreement. 3 months prior to your DSA expiry date you will be sent a notification to remind you that you need to consider either submitting a renewal or extension to your current Data Sharing Agreement to enable you to retain the data for a longer period or to destroy the data at the end of your DSA.

Slide 4

The start date of the DSA can be prior to the date of approval by exception.

For new applications the DSA start date cannot be in the past but must not be more than 12 months in the future.

The maximum agreement length from anticipated date of signature to agreement end date can be one of the following:

  • Archiving data in relation to academic research purposes – this is where no further processing needs to be carried out but data does need to be retained for at least five years – up to five years 
  • If you have stated that your application has a commercial aspect to it –  1 year 
  • If your agreement involves Sub-licencing – up to 1 year 
  • Anything else – up to 3 years

Slide 5

The DSA end date should take account of the following:

The data being required is for the period of the stated purpose(s) – if your analysis will be completed within six months and the data does not need to be retained beyond that date then the agreement end date should reflect that. 

The end date should not be longer than any fixed end date specified in any of your supporting material…. for example if you are relying on s251 support for the common law duty of confidentiality and your approval has a specific end date then the end date of your agreement should tie in with that – If you are planning to renew your s.251 approval then we would assume that you would submit your renewal annually and therefore you can select the appropriate end date as previously described.

For clinical trials, medical files should be retained for at least five years (Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (section 18 and 28) or successive legislation) – If processing has completed then you can opt for the 5year archiving DSA length.

An end date beyond the period of analysis may be accepted if justified (as documented in the objectives section of the application) by:

  • One of the above reasons
  • by a document of requirement of a funder 
  • or some other formal requirement for example a research council standard

Slide 6

When submitting your application via DARS online under the DSA Details tab you will be asked for your proposed agreement length - this will either be 12 months, 3 years or 5 years as described earlier in the presentation. You will also be asked to complete the start and end date of your agreement.

Slide 7

Thank you for listening. We would welcome your feedback on this presentation, if you would like to provide feedback then please email us at enquiries@nhsdigital.nhs.uk.

Last edited: 28 July 2021 4:12 pm