CFR Part 11: Electronic Records & Signatures

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Questions and Answers

What defines a closed system in the context of electronic records?

Contains only public domain records.

Access controlled by responsible persons for content. (correct)

Accessible to anyone without restrictions.

Open to external parties for modifications.

Which condition must be met for researchers to obtain informed consent according to Subpart B -- 50.20?

Information must be presented in a complex legal language.

Consent may include waivers of liability.

Consent can be obtained during the research activity.

Subjects must have adequate time to decide without coercion. (correct)

What does Subpart B -- 50.23 outline regarding exceptions to informed consent requirements?

Informed consent can be postponed indefinitely.

Certain conditions may allow for waiving informed consent. (correct)

Informed consent is always possible in life-threatening situations.

Consent is always required, regardless of circumstances.

What is the prerequisite for beginning a study?

Submission of the protocol to FDA for review and IRB approval Signup and view all the answers

Which of the following factors could prevent obtaining informed consent as per Subpart B -- 50.23?

Communication issues with the subject. Signup and view all the answers

When should an amendment be submitted for changes in a study?

For changes that significantly affect safety, scope, or scientific quality Signup and view all the answers

What must be included in informed consent forms according to Subpart B -- 50.20?

Information presented in an understandable language. Signup and view all the answers

What should a researcher do when adding a new investigator to an existing protocol?

Notify the FDA within 30 days Signup and view all the answers

What is the primary focus of Phase 2 clinical trials?

Confirm effectiveness for specific indications Signup and view all the answers

What must be clearly identified in a protocol amendment?

The type of amendment being submitted Signup and view all the answers

During which phases does the FDA also evaluate scientific quality in addition to subject safety?

Phase 2 and Phase 3 Signup and view all the answers

What characterizes an open system regarding electronic records?

System access is uncontrolled by content owners. Signup and view all the answers

What is required in the initial IND submission?

General investigational plans and specific study protocols Signup and view all the answers

What is required in the submission of a new protocol?

A summary of key differences from previous protocols Signup and view all the answers

According to Subpart B, under what circumstances is informed consent deemed not feasible?

Time constraints in emergencies. Signup and view all the answers

Which of the following is NOT included in the Cover Sheet (Form FDA-1571)?

Approval from all clinical trial participants Signup and view all the answers

When should amendments for new or changed protocols be submitted?

Before their implementation Signup and view all the answers

What is a basic requirement for informed consent as per Subpart B -- 50.20?

It should not include clauses that waive legal rights. Signup and view all the answers

What must essential information not covered by other reports include?

New toxicology, chemistry, or technical information Signup and view all the answers

What must amendments to IND submissions be supported by?

New or revised information, including animal studies Signup and view all the answers

What might researchers consider if multiple protocol amendments are submitted in a short period?

Combining them into a single submission Signup and view all the answers

Which section outlines the FDA review objectives regarding the safety of subjects?

FDA Review Objectives Signup and view all the answers

Which of the following details should NOT be included in the Introductory Statement and General Investigational Plan?

Information on drug costs Signup and view all the answers

What is the general requirement for monitoring personnel mentioned in the Cover Sheet?

Must be independent from the sponsor Signup and view all the answers

What must sponsors obtain from investigators before allowing their participation in a study?

Signed Investigator Statement (Form FDA-1572) Signup and view all the answers

Which information is NOT required in the Signed Investigator Statement?

Financial disclosures from all study participants Signup and view all the answers

What is the primary role of the selected monitor in a clinical investigation?

To oversee the investigation's progress Signup and view all the answers

Which detail is essential for Phase 2 or Phase 3 clinical protocols?

Estimated study duration Signup and view all the answers

In an emergency research under §50.24, what must sponsors do?

Monitor investigations with informed consent exceptions Signup and view all the answers

Which of the following is a requirement for public disclosures under the regulations?

Prompt submission of disclosed information to the IND file Signup and view all the answers

What type of information does the Clinical Protocol for Phase 1 studies include?

General outline and maximum subjects Signup and view all the answers

Which of the following is NOT a commitment that must be included in the Investigator Statement?

Recruit a specific number of participants Signup and view all the answers

What is one purpose of the FDA's focused regulatory research?

To enhance understanding and improve drug development processes. Signup and view all the answers

Which safeguard is mandated for drugs under the focused FDA regulatory research?

Review by institutional review boards (IRBs). Signup and view all the answers

What must happen before initial human testing of a new drug?

Animal studies must be reviewed. Signup and view all the answers

What is a requirement for an investigational new drug (IND) to be imported?

It must be subject to an active IND. Signup and view all the answers

How are adverse reactions to drugs monitored postmarketing?

By mandatory postmarketing reporting. Signup and view all the answers

What aspect of drug development may the FDA focus on during regulatory research?

Long-term use of the drug over extended periods. Signup and view all the answers

Which phase of drug development does the FDA's focused regulatory research NOT typically address?

Social media marketing campaigns. Signup and view all the answers

What is one of the goals of the FDA's focused regulatory research?

To facilitate the development of therapies for severe illnesses. Signup and view all the answers

Study Notes

Part 11 -- Electronic Records; Electronic Signatures

Closed systems restrict access to authorized individuals responsible for the content of electronic records.
Open systems allow access without control by responsible individuals, increasing potential risks.

Part 50 -- Protection of Human Subjects

Informed Consent Requirements:
- Legally effective informed consent is mandatory from human subjects or their representatives before research participation.
- Consent must allow adequate decision-making time while minimizing coercion risk.
- Information must be presented in understandable language.
- Exculpatory language waiving legal rights or releasing liability for negligence is prohibited.
Informed Consent Feasibility (Subpart B – 50.23):
- Exceptions are allowed in life-threatening scenarios where consent cannot be obtained due to communication barriers, time constraints, or the absence of alternative therapies.

Clinical Trial Phases

Phase 2:
- Focuses on evaluating effectiveness for specific indications and identifying short-term side effects using several hundred patients.
Phase 3:
- Expanded trials involve hundreds to thousands of subjects to confirm drug effectiveness and safety, forming the basis for physician labeling.

IND Submission Requirements

FDA Review Objectives:
- Ensure safety and rights of subjects throughout all trial phases.
- Evaluate scientific quality and effectiveness in Phases 2 and 3.
Submission Information:
- Varies based on drug novelty, prior studies, associated risks, and trial phase.
- Initial submissions should cover overall investigational plans and specific protocols.

IND Content and Format

Cover Sheet (Form FDA-1571):
- Must include sponsor details, investigational drug name, phase information, regulatory commitments, and monitoring personnel.
Table of Contents:
- Should include drug details, previous experience, and conditions for study initiation (FDA and IRB approvals).
Protocol Amendments:
- Amendments must be submitted for significant changes impacting safety or study design, and must be approved by FDA and IRB prior to implementation.

Information Amendments (Subpart B - §312.31)

Essential information not included in protocol amendments or safety reports must be reported, such as new toxicological or technical data.

Monitoring and Oversight

Sponsors must choose qualified monitors to oversee clinical trial progress.

Emergency Research under §50.24

Investigations involving exceptions from informed consent require stringent monitoring by sponsors.

Focused Regulatory Research (Subpart E - §312.86)

FDA's discretionary research focuses on drug development phases to address public health needs for serious illnesses.

Safeguards for Patient Safety

All regulations concerning patient safety before and during trials are upheld, including requirements for informed consent and institutional review board oversight.

Import and Export Requirements (Subpart F - §312.110)

Investigational new drugs may be imported if they are under an active IND according to set regulations.

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Description

Explore the key elements of Part 11 of the Code of Federal Regulations that govern Electronic Records and Electronic Signatures. This quiz will test your understanding of closed and open systems, as well as the regulatory environment surrounding electronic documentation. Perfect for students and professionals in compliance and information technology fields.