Decentralised & Digital Trials Certification — Professional

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1. Module 1

   M1

   1 lesson

   1. Locked.What “decentralised” actually meansLocked

      On completion you will be able to

      • R State the ICH E6(R3) Annex 2 definition of decentralised elements and explain why it is framed around activities, not around trials.
      • A Classify every trial-related activity in a supplied protocol as at, or outside, the investigator's location.
      • A Distinguish decentralised elements, pragmatic elements and the incorporation of real-world data, and identify which are present in a design.
      • A Place a design on the spectrum from fully site-based, through hybrid, to fully remote, and justify the placement.
      • N Explain why "is this a DCT?" is the wrong question and what the right one is.

2. Module 2

   M3

   1 lesson

   1. Locked.Regulatory framework II: jurisdictions, and the protocol/IRB interfaceLocked

      On completion you will be able to

      • A State the EU framework (EU) and cite the EC recommendation paper correctly by title, date and publisher.
      • A State the UK position (UK) including the amending instrument, its making date and its in-force date.
      • N Distinguish decentralised trial conduct from decentralised manufacture of investigational medicinal products, and explain why the two are conflated.
      • R Name the two final FDA guidances governing decentralised elements and remote data acquisition (US), with their status, dates and the drafts they finalise — and state honestly that their body text is not part of this curriculum's verified base.
      • N Draft the protocol text describing and justifying a decentralised element, and decide what belongs in the protocol versus a protocol-related document.
      • A Prepare the IRB/IEC-facing description of a decentralised methodology.
      • A Recognise that pandemic-era national flexibilities were temporary and reason from the permanent framework.

3. Module 3

   M4

   1 lesson

   1. Locked.Informed consent obtained remotely, and eConsent designLocked

      On completion you will be able to

      • N Design a consent process for a trial with decentralised elements and document the modalities in the protocol.
      • A Specify how the investigator will assure themselves of the participant's identity when consent is taken remotely, and pre-specify the verification method and the privacy safeguards.
      • N Assess whether a population's characteristics make a computerised consent process appropriate, and design the alternative pathway.
      • A Draft the consent-material disclosure of what data are collected, how they may be used, and which parties will access the participant's personal information — including health records and home address.
      • N Design multi-modal consent information that supports understanding rather than demonstrating production values.
      • A Determine the consent or permission basis for secondary use of data and RWD in a given region.

4. Module 4

   M5

   1 lesson

   1. Locked.Remote visits, usual clinical practice and investigator oversightLocked

      On completion you will be able to

      • N Design a visit schedule specifying, per visit and procedure, location and performer.
      • N Determine the appropriate level of investigator oversight for a given activity and justify it against criticality and risk.
      • A Classify a trial-related activity performed by a healthcare professional as requiring, or not requiring, knowledge of the protocol, investigator's brochure or trial-related documents — and apply the correct arrangements.
      • A Specify the arrangements for activities not requiring protocol knowledge: how data are shared, how records are retained including certified copies, how privacy is maintained, and what ensures data integrity.
      • N Design telehealth visit conduct as a documentation and data-capture problem, identifying what cannot be done remotely.

5. Module 5

   M6

   1 lesson

   1. Locked.Home nursing, mobile units and service-provider oversightLocked

      On completion you will be able to

      • N Assess a home-nursing or mobile-research-unit provider's suitability for a given trial.
      • A Identify who decides on a service provider's appropriateness and who holds oversight when the sponsor arranged the provider.
      • N Design the information flow from a home visit to the investigator such that it supports decisions on participant care.
      • A Specify what personal information each service provider requires, and the safeguard attached to each disclosure.
      • N Identify the local licensure and scope-of-practice questions a home or mobile delivery model raises, and identify who must resolve them.

6. Module 6

   M7

   1 lesson

   1. Locked.Direct-to-participant investigational product supply and accountabilityLocked

      On completion you will be able to

      • N Design an IMP supply model for a decentralised element covering supply, storage, dispensing, administration, return, accountability documentation and destruction or alternative disposition.
      • A Distinguish investigator/institution-arranged from sponsor-arranged shipment and state precisely what changes.
      • A Address all five matters Annex 2 §2.3.1 requires when shipping IMP to a participant.
      • N Assess an IMP's suitability for direct-to-participant supply against the §3.6.1 factors.
      • A Ensure sponsor-initiated shipment occurs only after investigator authorisation.
      • N Design blinding protection through a decentralised supply chain.
      • A Determine when existing pharmacy or institutional documentation suffices.

7. Module 7

   M8

   1 lesson

   1. Locked.Digital health technologies and digital endpointsLocked

      On completion you will be able to

      • N Determine whether a proposed DHT is fit for purpose for its intended role, and document the assessment including validation status.
      • A Distinguish verification, analytical validation and clinical validation as three separate evidentiary questions, and identify which is unanswered in a given evidence package.
      • N Specify a digital endpoint: measurand, technology, context of use, analysis, and clinical meaningfulness argument.
      • A Apply the DAT consequences to a wearable — validated and ready before use, accompanied by relevant metadata, not under exclusive sponsor control.
      • N Plan participant-facing DHT logistics and treat gaps in them as risks.
      • A Specify how DHT-generated safety information reaches the investigator "relevant, meaningful and manageable".

8. Module 8

   M9

   1 lesson

   1. Locked.ePRO, eCOA and instrument migrationLocked

      On completion you will be able to

      • A Select an ePRO/eCOA instrument appropriate to a population and endpoint.
      • N Assess a proposed migration from paper to screen as a minor, moderate or substantial change, and specify equivalence evidence proportionate to it.
      • A Design ePRO administration: windows, reminders, missed-entry rules, back-entry rules and their justification.
      • N Identify the analysis consequences of an instrument change made mid-study.
      • A Ensure the investigator has timely access to ePRO data affecting eligibility, treatment or safety without breaking blinding.

9. Module 9

   M10

   1 lesson

   1. Locked.Data flow, remote source access and oversight architectureLocked

      On completion you will be able to

      • N Draw a complete data flow for a trial with decentralised elements, identifying every originator, transfer and control point.
      • A Identify the source record for every data element and confirm the investigator has defined it before the trial starts.
      • N Determine the extent of sponsor access to individual-level data and to data in source records that a use case requires, proportionate to criticality.
      • A Specify arrangements where data are owned or controlled by another entity, including regulatory-authority access for inspection.
      • N Design remote monitoring including remote read-only source access, and state the site's obligations in granting it.
      • A Specify data-linkage rules including pre-specification and inconsistency resolution.
      • N Design sponsor oversight across many service providers.

10. Module 10

    M11

    1 lesson

    1. Locked.Privacy, equity and jurisdictionLocked

       On completion you will be able to

       • A Identify every point at which a participant's personal information reaches a party who would not receive it in a conventional trial, and specify the safeguard.
       • N Assess data-protection obligations for continuously-collected data and allocate controller and processor roles across the parties.
       • N Assess a decentralised design for participant equity in both directions — who it includes and who it excludes.
       • A Identify the local licensure and cross-jurisdiction questions a design raises and who must resolve them.
       • N Assess breach risk for DHT and RWD data and specify mitigation.

11. Module 11

    M12

    1 lesson

    1. Locked.Risk assessment and integrated capstoneLocked

       On completion you will be able to

       • N Conduct a risk assessment of a trial's decentralised elements and produce proportionate controls.
       • N Integrate the programme: take a conventional protocol, propose a decentralised design, justify each element, and document the oversight, data, privacy and equity consequences.
       • N Defend the design against challenge, and identify the elements you would drop first under pressure.