NHS Digital Data Release Register - reformatted

Janssen-cilag Limited projects

2 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).


A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older — DARS-NIC-409280-J6T3M

Opt outs honoured: Identifiable (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: Yes (Supplier)

Sensitive: Non-Sensitive

When:DSA runs 2020-11-16 — 2021-03-31

Access method: One-Off

Data-controller type: JANSSEN-CILAG LIMITED

Sublicensing allowed: No

Datasets:

  1. Permission to Contact

Expected Benefits:

The primary benefit of using the data will be to recruit participants for the clinical study/trial in a manner which:
• Enables individuals to volunteer in advance to participate in COVID-19 vaccine trials as an alternative to other potentially more intrusive mechanisms, e.g. sharing data with researchers about individuals under section 251 consents or COPI notices, which although lawful is initially less transparent.
• Allows researchers to identify a suitable cohort and recruit them quickly into the vaccine trials – thus reducing the overall time to recruit into the trials and to accelerate the delivery of an effective vaccine to treat individuals to manage the COVID-19 outbreak and to save lives.
• Reduces burden on research staff in identifying and contacting potential clinical trial participants.
• Supports the Vaccines Taskforce objectives to drive forward, expedite and coordinate efforts to research and then produce a coronavirus vaccine and make sure one is made available to the public as quickly as possible.

Outputs:

The information from NHS Digital will be used to facilitate contact with individuals who are potentially eligible and who have indicated willingness to potentially participate in studies/trials of COVID-19 vaccines.

This is expected to result in individuals entering the trials screening process with a view to them participating in the trial with fully informed consent.

The main results from this trial are expected to inform development of a safe and effective vaccine against COVID 19.