Investigator-Initiated Trial Management Certification — Professional

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1. Module 1

   M1

   1 lesson · 12 h

   1. Locked.Deciding whether to become a sponsor12 h · Locked

      On completion you will be able to

      • By the end of this module, the candidate can:
      • Apply 21 CFR 312.2 and 812.2 to determine whether an IND or IDE is required for a described study, and produce a written determination with reasoning.
      • Distinguish the §312.2(b)(1) marketed-drug exemption from the §312.2(d) practice-of-medicine provision, and explain the distinction to a non-regulatory audience.
      • Draft a §312.2(e) request for FDA's advice where the determination is genuinely uncertain.
      • Enumerate, before any Form FDA 1571 is signed, what accepting the sponsor role costs in named obligations, named people and named infrastructure.
      • Identify the situations — expanded access above all — in which an individual becomes a sponsor-investigator without intending to.

2. Module 2

   M2

   1 lesson · 16 h

   1. Locked.The dual role, and where the two halves conflict16 h · Locked

      On completion you will be able to

      • Map every sponsor obligation and every investigator obligation for a described study onto named individuals, and identify every point at which one person holds both sides.
      • Design a specific control for each of the six named conflicts.
      • Apply §312.52 to a proposed obligation transfer and identify what has not been transferred.
      • Distinguish obligations that may be delegated from those that may not, and state the regulatory basis for each.

3. Module 3

   M3

   1 lesson · 10 h

   1. Locked.Protocol, Investigator’s Brochure and the investigational plan10 h · Locked

      On completion you will be able to

      • Author or review a protocol meeting §312.23(a)(6)(iii)'s content requirements at a depth proportionate to phase.
      • Determine correctly whether an investigator's brochure is required, and where it is not, design and document a substitute — labelled explicitly as practice, not regulation.
      • State precisely what §312.55(b) still requires of a sponsor-investigator who is relieved of the IB obligation under §312.55(a).
      • Author a device investigational plan meeting §812.25.

4. Module 4

   M4

   1 lesson · 14 h

   1. Locked.Sponsor-level safety reporting14 h · Locked

      On completion you will be able to

      • Apply the three-part §312.32(c)(1)(i) threshold and identify which clock applies and what event starts it.
      • Operate and evidence the sponsor's distribution obligation to FDA and all participating investigators.
      • Apply the device safety obligations at §812.46 and §812.150(b) with their working-day clocks.
      • Reconcile a year's safety reports against the §312.33 annual report.

5. Module 5

   M5

   1 lesson · 14 h

   1. Locked.Data and safety monitoring, and discharging §312.5014 h · Locked

      On completion you will be able to

      • Author a data and safety monitoring plan proportionate to risk, stating what each element is required by (or honestly, that it is not).
      • Determine whether a DSMB or DMC is required, and where it is a design choice rather than a regulatory mandate, establish one to a defensible standard.
      • Design how a single-site academic sponsor with no monitoring department discharges §312.50's "proper monitoring" obligation, and evidence that it was discharged.
      • Distinguish sponsor monitoring, data and safety monitoring, and IRB continuing review, and identify which obligation a given activity actually satisfies.

6. Module 6

   M6

   1 lesson · 8 h

   1. Locked.Multi-site IITs, the coordinating centre, and registration8 h · Locked

      On completion you will be able to

      • Identify which sponsor obligations become materially harder at more than one site, and design the coordinating-centre function that discharges each.
      • Obtain and maintain the correct investigator instrument (1572 for drugs; the §812.43(c) investigator agreement for devices — not a form).
      • Advise correctly on IRB arrangements for a multi-site FDA-regulated study, including the real absence of a single-IRB mandate outside HHS-supported cooperative research.
      • Determine, execute and, where necessary, withdraw a ClinicalTrials.gov responsible-party designation.

7. Module 7

   M7

   1 lesson · 8 h

   1. Locked.Essential records, the sponsor TMF and inspection exposure8 h · Locked

      On completion you will be able to

      • State what records the sponsor must hold, distinct from what the site holds, and design a file architecture that keeps both.
      • Apply the ICH E6(R3) essentiality test rather than a fixed document list.
      • Apply the correct retention rule and identify why neither is a fixed number of years from study end.
      • Prepare an institution for a sponsor inspection, as distinct from a site inspection.

8. Module 8

   M8

   1 lesson · 18 h

   1. Locked.Product supply, agreements, funding and institutional infrastructure18 h · Locked

      On completion you will be able to

      • Design investigational product supply, labelling, accountability and disposition for an academic sponsor.
      • Identify the regulatory constraints on obtaining product by compounding, and recognise when to escalate rather than proceed.
      • Read an industry-supplied-drug agreement for the terms that determine whether a study is regulatorily feasible and who controls it.
      • Apply §312.8 where an institution proposes to charge for investigational product.
      • Advise an institution on the infrastructure a functioning IIT programme needs, and articulate what is missing without it.