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Scoping project requirements

The following steps below demonstrate the event sequence of interactions between the project team and HIC to discuss and scope project requirements before funding is secured and, when the project is given the go-ahead.

Pre award

Step 1: User defines questions and develops a project plan and organise a pre-award project scoping meeting

  • HIC can help by providing a dataset inventory list
  • Provide an aggregate feasibility data

Contact to request a pre-award project scoping meeting with the HIC Data Team. We will discuss project feasibility, data and approval requirements.

To enable HIC to understand the project requirements and provide an accurate costing the following information is needed:

  • Project title
  • Project aims
  • How the cohort will be defined
  • Geographic areas to be covered
  • Whether there is linkage to external data not held by HIC
  • Longitudinal data history required
  • How up-to-date the data will need to be
  • When the data is likely to be needed
  • How the project will be funded
  • Software requirements
  • If you can’t answer these questions straight away, we can work together to help you complete this.

Step 2: Quotation generation

HIC will provide a quotation based on the discussion, for agreement with the Principle Investigator (project leader) prior to submission for funding.

Please allow 4 weeks before any grant application processing deadline to meet, assess requirements, and for HIC to calculate costs and provide a quotation.

HIC operated on a cost-recovery basis.  We do not sell data, but there is a charge for our services.  This is to cover our staff time in preparing your project extraction, time within our Trusted Research Environment and contributes  to HIC background running costs.

The quote may be subject to VAT. 

Step 3: Project approvals and governance

HIC operate a streamlined governance model for retrospective data analysis projects using our TRE (Trusted Research Environment).  Your project may benefit from this, but if it doesn’t rest assured, we can advise and assist you in meeting your project’s needs.

Step 4: Funding

  • Data user applies for funding 

Project start

Step 5: Data requirement user meeting (DRUM)

Once the agreed funding has been awarded or identified get back to us to hold a project start DRUM (data requirement user meeting) to confirm details from the quotation, agree a delivery schedule & project milestones, including a communication strategy for providing feedback at key delivery points.  HIC will confirm the necessary approvals that will be needed, in dialogue with our Information Governance Manager and external governance officials, as required. This is an important meeting to help ensure efficient delivery of accurate data for the project.

All relevant project staff to attend, in particular the Principal Investigator (PI) and the Research Assistant (RA) who will be carrying out the analysis, along with key senior and junior HIC staff who will be involved in the data extraction. This helps to reduce misunderstanding over data requirements and delivery dates.

The outcome of this step is a Data Requirement Specification document which  will be provided to the PI and RA for confirmation that this is the correct data extract for the study.

The PID defines how the cohort will be made:

  • Inclusion and exclusion criteria
  • Detailed data to be provided, within scope of the original quotation
  • Delivery schedule
  • Communication strategy
  • Governance approvals required

Delivery dates are dependent on:

  • Confirmation of data requirement specification by PI and RA
  • Necessary governance approvals being obtained
  • Timely receipt of any external data required for linkage to HIC-hosted data

Step 6: Agreeing the project requirements

Once the DRS has been agreed and the project has begun all subsequent requests for changes to requirements and project scope will require an impact assessment to be performed.

The outcome of the process is one of the following situations:

  • A schedule slippage
  • Additional project costs
  • No-cost alteration to scope
  • No impact
  • Schedule slippage and additional project costs

The PI will be asked to review the impact assessment and to decide whether they wish to proceed with the change and agree to any associated impacts to original costs and schedule.

Step 7: Data extraction and trusted research environment

Once governance approvals are in place, HIC can extract your project dataset and provide access to it in our TRE.  This is when the agreed project timelines begin.  Our TRE is designed to enable research without the need to give data outside of our security model.  This helps to minimise risk to patient’s confidentiality, allows collaboration with any other members of your research team and means you don’t have to worry about backups.

Any delays or errors caused by HIC will be rectified at no cost to the project. If these errors are discovered 30 days beyond the release, there may be a delay in responding to your queries due to existing commitments.

Data archiving

Step 8: The project is archived

Once the project has reached its end date HIC will liaise with the study team to ensure that they are finished with the data. If they are not an extension can be arranged.  This may incur an additional charge.

When the data user confirms that their project is completed the project dataset will be removed from the TRE and archived for 10 years. The dataset can be made available again on request if necessary, with any applicable new approvals and funding. After 10 years the data will be reviewed by HIC to authorise either holding it longer or deleting it.

The archived data project folder will contain:

  • The original data supplied for the study
  • The project folder from within the TRE. This will also contain any data user analysis code to enable the study to be re-run if necessary, e.g. to prove findings
  • The project folder used by HIC to hold any requirements, code etc.
  • Extracted version of any temporary database tables relating to HIC building the project dataset.  These will also be removed from production servers

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