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Domain 3: Investigational Products Development and Regulation

Encompasses knowledge of how investigational products are developed and regulated


3.1

Discuss the historical events that precipitated the development of governmental regulatory processes for investigational products

Fundamental Level:

A1.       Identify the key historical events that took place which influenced the current regulatory environment that exists today (both FDA and internationally)

Example: Understands why the inclusion and exclusion criteria for women of childbearing potential sometimes exists in a clinical study.

Skilled Level:

B1.       Demonstrate an understanding of current events that have influenced guidelines and regulatory processes with regards to FDA regulations and guidelines as well as those on a global scale

Example: Locates and describes FDA’s guidance on genomics in clinical research.

Advanced Level:

C1.       Predict and/or construct adaptation plans for the new releases of existing regulations and ICH Guidelines

C2.       Support cross-functional team efforts, provide teaching to internal staff, investigators, and other stakeholders about pending or current guidance or regulations, such as the documentation about training planned for updated ICH E6

Example: Creates a risk-based monitoring plan for a new clinical trial to ensure compliance with FDA regulations and ICH GCPs.


3.2

Describe the roles and responsibilities of the various institutions participating in the investigational products development process

Fundamental Level:

A1.       Identify differences between responsibilities of investigators, sponsors, CROs and regulatory bodies

A2.       Demonstrate understanding of the role of IRBs in approving protocols, assessing risk, and determining exemptions

Example: Describes the role of an investigator as described in FDA 1572 and the delegation of responsibilities from sponsor to a CRO.

Skilled Level:

B1.       List specific roles and responsibilities for each of the institutions participating in the investigational products development process, (investigators, sponsors, CROs and regulatory bodies)

B2.       Recognize the scope of responsibilities of monitoring organizations like Research Pharmacy, Data Safety Monitoring Boards

Example: Explains the information required and processes used by the IRB in approving protocols, assessing risk, and determining exemptions.

Advanced Level:

C1.       Evaluate the study protocol to determine the need for collaboration between various institutions/organizations

C2.       Define the roles and responsibilities of the institutions required to complete a research project

Example: Assesses the need and develops a request for proposal for hiring a CRO to conduct monitoring activities for a multicenter trial.


Fundamental Level:

A1.       Understand concepts, major elements and objectives of investigational products development life cycle management process for investigational products

Example: Has a basic understanding of the drug development and approval process and recognizes the need to obtain approval from the FDA to market the investigational products in US. Maintains site’s IP tracking log at, CRFs, and is familiar with IB or Device Manuals.

Skilled Level:

B1.       Interpret and execute the concepts, major elements, and objectives of investigational products development life cycle management process for medical products

Example: Uses the FDA website to determine whether a clinical study using investigational products requires an IND or IDE or letter of exemption.

Advanced Level:

C1.       Evaluate an established or create a strategic investigational products development and life cycle management plan

C2.       Coordinate an IP development plan with regulatory authorities

C3.       Distinguish between the regulatory approval processes for drugs, biologics and medical devices

Example: Develops and formulates a request for orphan drug designation for a new investigational product.

3.3

Explain the investigational products development process and the activities which integrate commercial realities into the life cycle management of medical products


Fundamental Level:

A1.       Describe how to access the appropriate regulatory guidance that applies to the development and registrations of IMPs, and the clinical trials process required to register such products in their geographical location. (US-FDA, Europe-EMeA, UK-MHRA)

A2.       Demonstrate basic knowledge of Human Subjects Protection and ICH GCP guidelines

Example: Accesses the relevant guidance in their country for: Informed Consent, Drug Development and approval, IRBs/ECs, Conflict of interest, Investigator responsibilities, Sponsor responsibilities

Skilled Level:

B1.       Describe and apply federal (US, EMA, or other) regulatory laws and guidance during the performance of complex clinical research operations.

B2.       Interpret the requirements of ICH GCP, the approved study protocol and sponsor study related SOPs.

B3.       Execute the development or editing of study related SOPs, reports, and / or submission for the relevant regulatory approval of the study.

Example: Describes how regulations and guidance are applied in harmony with ICH GCP requirements, Health Research Authority approvals processes, Research Ethics Committee Approvals and through the comprehensive recording of study related conduct through the maintenance of an investigator site file.

Advanced Level:

C1.       Provide oversight and train others in relation to the relevant authority and associated regulatory frameworks, including how these harmonize with ICH GCP, the approved study protocol, and sponsor study related SOPs to ensure the safety and rights of study participants

C2.       Monitor the progress and assure that conduct of studies at site meets  local, national and global regulatory frameworks, and support others to meet such requirements in the conduct of trials

Example: Produces training guides, documentation, and checklists to enable study delivery staff to ensure that the relevant regulatory framework is adhered to in relation to specific studies.

3.4

Summarize the legislative and regulatory framework that supports the development and registration of investigational products and ensures their safety, efficacy and quality


Fundamental Level:

A1.       Describe the specific activities and purposes of preclinical and clinical research and how they contribute to the filing of an IND and an NDA/CTA/BLA

A2.       Recognize how Phase 1-3 data contributes to the filing of an IND and NDA

Example: Participates in the collection of documents necessary for submission of an NDA.

Skilled Level:

B1.       Actively participate in the implementation of Phase 1-3 clinical trials

B2.       Differentiate between the purposes of the IND, NDA, BLA and each phase of clinical development and the relationship of research questions answered at each phase

Example: Uses the investigator brochure to understand and anticipate what types of potential safety risks might be associated with a clinical trial.

Advanced Level:

C1.       Appraise the potential and resources required for successful implementation of a preclinical or clinical research protocol

C2.       Supervise the development, clinical planning and implementation of a preclinical or clinical research protocol intended to contribute to a regulatory submission (e.g., IND, BLA, NDA) or clinical program

Example: Analyzes data and makes a go/no-go decision after Phase I data are analyzed.

3.5

Describe the specific processes and phases that must be followed for the regulatory authority to approve the marketing authorization for a medical product


Fundamental Level:

A1.       Identify the differences between adverse event reporting requirements for studies pre- and post- marketing approval 

A2.       Understand the reporting requirements for different types of adverse events

Example: Identifies adverse events that meet the criteria to be labeled ‘serious,’

Skilled Level:

B1.       Assess the occurrence and coordinate with investigator on classification of adverse events during the conduct of a clinical trial

B2.       Complete and submit adverse event reports, according to appropriate requirements and timeline

Example: Identifies, classifies, and codes an adverse event using source documentation and an appropriate coding dictionary.

Advanced Level:

C1.       Identify and interpret safety data (e.g., safety signals or data from surveillance systems)

C2.       Mentor and teach others to compare and contrast safety reporting requirements that may differ by region

C3.       Comply with a REMS program.

Example: Serves as the point of contact for both pre- and post-approval safety reporting issues and collaborates with others when responding to questions from regulatory agencies with regards to safety reporting.

3.6

Describe the pre- and post- approval safety reporting requirements of regulatory agencies


Fundamental Level:

A1.       Recognize that different national regulations may affect the medical product approval process

Example: Recognizes that GCP must be honored in multi-site trials, but that other national regulations may differ.

Skilled Level:

B1.       Compare regional regulations and how their differences could impact the conduct of trials or the review of medical product approvals

Example: When conducting a study in Japan, applies appropriate strategies to include the correct number of Japanese nationals as part of your study population, as required by the Japanese regulatory agency.

Advanced Level:

C1.       Develop and implement strategies for the conduct of multi-regional clinical trials

C2.       Develop and implement global strategies that optimize the required review and approval of a marketing application

C3.       Analyze the resources necessary to gain approval for medical products in multiple countries

Example: Knows that a regulatory application in another country may necessitate significantly more resources than a similar application in the US and provides multiple solution alternatives to address barriers to approval of medical products with strategies in alignment with international harmonization efforts (e.g., ICH, EU. WHO).

3.7

Appraise the issues generated and the effects of global expansion on the approval and regulation of medical products