Regulatory Affairs for Research Sites Certification — Foundation

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1. Module 1

   F-M1

   1 lesson · 5 h

   1. Locked.Which rules apply, and to whom5 h · Locked

      On completion you will be able to

      • On completion the learner can:
      • Classify a described study as FDA-regulated, Common-Rule-covered, both or neither, and state the basis for the classification.
      • Identify the sponsor, the investigator and any sponsor-investigator in a described arrangement, citing 21 CFR 312.3 or 812.3.
      • Locate the governing regulation for a described question.
      • Distinguish the vulnerable-population lists at 21 CFR 56.111 and 45 CFR 46.111 and explain why both are correct.
      • Name the EU and UK instruments and state their current status.

2. Module 2

   F-M2

   1 lesson · 7 h

   1. Locked.The IND question7 h · Locked

      On completion you will be able to

      • State the five conditions of 21 CFR 312.2(b)(1) and explain that all five must hold.
      • Apply the five conditions to a described study of a marketed drug and identify which condition is in issue.
      • Distinguish § 312.2(b)(1) from § 312.2(d) and explain why the distinction is not a technicality.
      • Explain the consequence of § 312.2(b)(4) for defensive filing.
      • Identify the situations where an IND is required notwithstanding the marketed status of the drug — including § 312.2(b)(6) EFIC.
      • Escalate a contested determination with a written statement of the issue.

3. Module 3

   F-M3

   1 lesson · 4 h

   1. Locked.The IDE question and the risk determination4 h · Locked

      On completion you will be able to

      • Apply each limb of 21 CFR 812.3(m) to a described device and identify that limbs (1)–(3) each require two findings.
      • Explain the abbreviated requirements at § 812.2(b)(1) and state that no application is submitted to FDA.
      • Identify the § 812.2(c) exempted categories and apply the four-part diagnostic-device test.
      • Distinguish significant risk from greater-than-minimal risk.

4. Module 4

   F-M4

   1 lesson · 6 h

   1. Locked.The regulatory file and the four forms6 h · Locked

      On completion you will be able to

      • Identify Forms FDA 1571, 1572, 3454 and 3455 by number, signer and governing regulation.
      • List the § 312.53(c)(1) contents of Form FDA 1572.
      • Explain that Form FDA 1572 has no application to a device study and describe the § 812.43(c) investigator agreement.
      • Audit a regulatory file against the obligations that generate its contents.
      • Distinguish regulatory obligations from sponsor and institutional practice in a file's contents.

5. Module 5

   F-M5

   1 lesson · 5 h

   1. Locked.Consent and the IRB, under two regimes5 h · Locked

      On completion you will be able to

      • List the elements required by 21 CFR 50.25 and contrast them with 45 CFR 46.116.
      • Apply the § 50.27(a) documentation requirement.
      • Distinguish §§ 50.22, 50.23 and 50.24 and identify which governs a described situation.
      • State the FDA continuing-review requirement without qualification and explain why the 2018 Common Rule relief does not reach it.
      • State the IRB position for FDA-regulated multi-site research.

6. Module 6

   F-M6

   1 lesson · 3 h

   1. Locked.Reporting, records and retention3 h · Locked

      On completion you will be able to

      • Apply § 312.64(b) to a described serious adverse event, including the study-endpoint provision.
      • Distinguish the investigator's "immediately" from the sponsor's 15 and 7 calendar days.
      • Apply the § 812.150(a) investigator clocks.
      • State the retention rules at § 312.62(c) and § 812.140(d).

7. Module 7

   F-M7

   1 lesson · 2 h

   1. Locked.Registration and results2 h · Locked

      On completion you will be able to

      • Determine whether a described trial is an applicable clinical trial.
      • Identify the responsible party.
      • State the § 11.24 and § 11.44 deadlines and the § 11.66 consequences.