Core Concepts in Clinical Research On-Demand Course

Purpose

To provide clinicians and aspiring researchers with a practical and comprehensive foundation in the principles of clinical research design, interpretation, and application, improving their ability to critically evaluate medical literature, apply insights to clinical practice, and conduct their own studies with confidence.

Target audience

Health care professionals of all career stages who wish to improve their ability to interpret medical research or prepare for a career in clinical research.

Funding source

None

Content
The course content was developed jointly by AMBOSS and NEJM Group physician authors and editors. All educational materials are based on best-practice guidelines and high-impact published studies that adhere to accepted standards of scientific evidence. Content is free of commercial bias and complies with the Accreditation Council for Continuing Medical Education (ACCME®)’s Standards for Integrity and Independence in Accredited Continuing Education.

Activity type

Enduring material

Method of participation

To earn AMA PRA Category 1 Credits™ for this activity, all of the following requirements must be met:

• Complete all 8 modules (i.e., for each module: read the linked NEJM article(s), watch the videos, and complete the assigned worksheets and practice multiple choice questions)
• Complete the post-course quiz and achieve a minimum score of 70%.
• Submit the activity evaluation.

Overall learning objectives

• Understand why specific study designs are chosen for research questions.
• Apply key concepts of biostatistics and epidemiology to study design.
• Define exposure, intervention, comparator, and primary outcomes in a trial.
• Formulate a clear, testable hypothesis.
• Interpret and evaluate high-impact clinical research.
• Identify study limitations and their implications for practice.

Session-specific learning objectives

Module 1-2: Cohort Studies

Colloquium

1. Understand the central concepts in cohort study design.
2. Identify the essential elements required to implement and present a rigorous cohort study.
3. Understand how and why specific core statistical designs and methods are applied to cohort studies.
4. Understand the importance of primary outcome differences to determine if cohort study results are positive, negative, or neutral.

Seminar and tutorial

1. Understand the methods used in cohort study data analysis.
2. Interpret primary outcome differences to determine if cohort study results can be used for future research.
3. Identify the study design, hypothesis, exposure of interest, comparator, and primary outcome in an NEJM cohort study.
4. Interpret the effect size, confidence interval, Kaplan–Meier survival estimate, log-rank test, and Cox proportional hazards model.
5. Understand how to determine if the cohort study was positive, negative, or neutral.

Module 3-4: Case-Control & Cross-Sectional Studies

Colloquium

1. Understand the central concepts in cross-sectional and case-control study design.
2. Identify the essential elements required to implement and present rigorous cross-sectional and case-control studies.
3. Understand how and why specific core statistical designs and methods are applied to cross-sectional and case-control studies.
4. Understand the importance of primary outcome differences to determine if cross-sectional and case-control study results are positive, negative, or neutral.

Seminar and tutorial

1. Understand the methods used in cross-sectional and case-control studies data analysis.
2. Interpret primary outcome differences to determine if cross-sectional and case-control study results can be used for future research.
3. Identify the study design, hypothesis, case subjects, control subjects, and primary outcome in an NEJM case-control study.
4. Interpret power calculations and logistic-regression estimates.
5. Understand how to determine if the case-control study was positive, negative, or neutral.

Module 5-6: Clinical Trials

Colloquium

1. Understand the central concepts in randomized controlled trial design.
2. Identify the essential elements required to implement and present a rigorous clinical trial.
3. Understand how and why specific core statistical designs and methods are applied to clinical trials.
4. Understand the importance of primary outcome differences to determine if trial results are positive, negative, or neutral.

Seminar and tutorial

1. Understand the methods used in randomized controlled trial data analysis.
2. Interpret primary outcome differences to determine if randomized controlled trial results can be applied to patient care.
3. Identify the study design, hypothesis, intervention, primary outcome, types of randomization, allocation concealment, and blinding procedures in an NEJM clinical trial.
4. Interpret power calculations and trial results including Kaplan–Meier survival estimate, log-rank test, Cox proportional hazards model, and effect size estimates.
5. Understand how to determine if the clinical trial was positive, negative, or neutral.

Module 7-8: Systematic Review and Meta-Analysis

Colloquium

1. Understand the central concepts in systematic review and meta-analysis design.
2. Identify the essential elements required to implement and present a rigorous systematic review and meta-analysis.
3. Understand how and why specific core statistical designs and methods are applied to meta-analyses.
4. Understand the importance of the quantitative summary of meta-analysis data to determine if systematic review results are positive, negative, or neutral.

Seminar and tutorial

1. Understand the methods used in conducting a meta-analysis.
2. Interpret meta-analysis results to determine if a systematic review can be used for future research and/or applied to patient care.

Disclosure policy statement

AMBOSS adheres to the policies and guidelines, including the Standards for Integrity and Independence in Accredited Continuing Education (CE), set forth to providers by the Accreditation Council for Continuing Medical Education (ACCME) and all other professional organizations, as applicable, stating that those activities in which continuing education credits are awarded must be balanced, independent, objective, and scientifically rigorous. All persons in a position to control the content of an accredited continuing education program provided by AMBOSS are required to disclose all financial relationships with any ineligible company within the past 24 months to AMBOSS. All financial relationships reported are identified as relevant and mitigated by AMBOSS in accordance with the ACCME Standards for Integrity and Independence in Accredited CE before learners participate in the activity. The content of this activity was vetted by AMBOSS to ensure objectivity and that the activity is free of commercial bias. All relevant financial relationships have been mitigated by AMBOSS.

Disclosure of relevant financial relationships

The following planners and managers for this activity have no relevant financial relationships with ineligible companies:

• Viola Welter: nothing to disclose
• Anne Sophie Albertowski: nothing to disclose
• Leonie Klaumünzer: nothing to disclose
• Paulina Lerner: nothing to disclose
• Nelly Scheidel: nothing to disclose
• Svantje von Glinowiecki: nothing to disclose
• Pavel Pavlov: nothing to disclose
• Milda Sukyte: nothing to disclose
• Manuel Fernández: nothing to disclose
• Yongmin Hwang: nothing to disclose
• Ilgin Üze: nothing to disclose
• Emma Ruderman: nothing to disclose

The following faculty, authors, and content developers have no relevant financial relationships with ineligible companies:

• Kenneth B. Christopher: nothing to disclose
• Jamie M. Robertson: nothing to disclose
• Sara Kalkhoran: nothing to disclose
• Alex Willis: nothing to disclose
• Camry Wilkinson-Reich: nothing to disclose

AMBOSS is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physician credit designation statement

AMBOSS designates this enduring material activity for a maximum of 19 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

American Board of Anesthesiology (ABA) MOCA 2.0® Program

This activity contributes to the CME component of the American Board of Anesthesiology’s redesigned Maintenance of Certification in Anesthesiology™ (MOCA®) program, known as MOCA 2.0®. Please consult the ABA website, www.theABA.org, for a list of all MOCA 2.0 requirements.

American Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) Program

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 19 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

American Board of Pathology (ABPath) Continuing Certification Program

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 19 Lifelong Learning points in the American Board of Pathology's (ABPath) Continuing Certification program. It is the CME activity provider’s responsibility to submit learner completion information to ACCME for the purpose of granting credit.

American Board of Pediatrics (ABP) Maintenance of Certification (MOC) Program

Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn up to 19 MOC points in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit learner completion information to ACCME for the purpose of granting ABP MOC credit.

American Board of Otolaryngology – Head and Neck Surgery (ABOHNS) Continuing Certification Program

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn their required annual part II self-assessment credit in the American Board of Otolaryngology – Head and Neck Surgery’s Continuing Certification program (formerly known as MOC). It is the CME activity provider's responsibility to submit participant completion information to ACCME for the purpose of recognizing participation.

American Board of Surgery (ABS) Continuous Certification Program

Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and Self-Assessment requirements of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit.

American Board of Thoracic Surgery (ABTS) Continuing Certification Program

Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and Self-Assessment requirements of the American Board of Thoracic Surgery’s Maintenance of Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABTS credit.

Original release date: May 31, 2026
Expiration date: May 30, 2029

In order to receive a Certificate of Credit (physicians) or a Certificate of Participation (non-physicians) for participation in this activity, learners must complete the evaluation and submit a request for credit.

The evaluation and credit submission request can be accessed at the conclusion of the course on your CME page via https://www.amboss.com/us. Ensure you are in the “Clinical Care” tab, then click on your profile at the top right and on “View your CME page.” Certificates will be automatically generated upon submission of the evaluation.

The deadline to claim credit is 30 days after the activity expiration date.

For further information about redeeming CME credit and MOC points, please see CME/MOC FAQ.