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DOMAIN 1: SCIENTIFIC CONCEPTS AND RESEARCH DESIGN

Encompasses knowledge of scientific concepts related to the design and analysis of clinical trials


1.1

Apply principles of biomedical science to investigational product discovery and development and health-related behavioral interventions

FUNDAMENTAL LEVEL:

A1.       Recognize the need to apply scientific principles to discovery and development of biomedical investigational products and health-related behavioral interventions                         

A2.       Explain the basic scientific principles that should be applied during development of biomedical investigational products and health-related behavioral interventions        

Example: When reviewing a clinical research protocol, researcher describes the objective and scientific techniques used to design and implement biomedical research.

SKILLED LEVEL:

B1.       Apply scientific principles when implementing a clinical or behavioral study

B2.       Implement data collection according to scientific principles and based on protocol design

Example: When given a clinical research protocol, researcher differentiates what principles could affect how the data should be collected and implement best practices accordingly.

ADVANCED LEVEL:

C1.       Plan biomedical research according to scientific principles

C2.       Develop a data management plan according to scientific principles

Example: Given a clinical research protocol and data collected, the researcher evaluates the findings to assess results via a scientific framework.


1.2

Identify scientific questions that are potentially testable clinical research hypotheses

Fundamental Level:

A1.       Articulate the purpose of the study

A2.      Describe the importance of the study

Example: Identifies the following elements in selected study protocols: Study title, Key purpose of the study, Why this study is important to be done, Who the specific population for the study is

Skilled Level:

B1.       Identify the research hypothesis in a study protocol

B2.       Identify endpoints (primary and secondary) that will be used in data analyses to measure outcomes

Example: When given a study protocol, describes and classifies the objectives and associated safety and efficacy endpoints that will be used to test the hypothesis and identify assessments (clinical, social/ behavioral, or economic) that will be used to measure endpoints.

ADVANCED LEVEL:

C1.       Develop protocol or source document checklist language that identifies the scientific questions (hypotheses), primary objectives, secondary objectives, and associated endpoints

C2.       Align parameters for collecting data on endpoints with objectives

Example: Develops presentations to educate others on the scientific feasibility and conduct of the study to ensure quality collection of endpoints for hypothesis testing.


1.3

Identify the elements and explain the principles and processes of designing a clinical study

fundamental level:

A1.       Identify the key elements of a clinical study protocol

A2.       Describe the general process of clinical study protocol development

A3.       Recognize the basic differences between the various types of clinical studies

Example: When given a clinical study protocol, identifies the inclusion and exclusion criteria for a set of mock participants.

skilled level:

B1.       Review a clinical study protocol to ensure all needed elements are included

Example: When given a clinical study protocol, identifies missing, incomplete or inappropriate features.

advanced level:

C1.       Evaluate the clinical study design and make adjustments to the processes as needed

C2.       Develop protocols as applicable to the therapeutic area

C3.       Evaluate strengths and weakness of study designs and explain these to others

Example: When given a clinical study protocol that has misalignment between the measures and objectives, researcher appropriately modifies the protocol.


1.4

Critically analyze clinical study results


Fundamental Level:

A1.       Identify the study results

A2.       Describe the relevance of the results to the research question

Example: When given study reports, paraphrases and summarizes the study results.

Skilled Level:

B1.       Compare and assess the level of quality of results associated with study reports and publications

B2.       Understand descriptive and exploratory data analysis

Example: When given two publications researching the same topic, researcher compares and contrasts what could have affected how the data from the two could be interpreted.

Advanced Level:

C1.       Assess the potential for application of findings

C2.       Identify trends and anomalies within the clinical study data

Example: Conducts pharmacovigilance assessments of collected data and generates queries to close data gaps