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Course syllabus for APM in Clinical Research

This course syllabus is intended to itemize the minimum necessary requirements for a course to be suitable for the theoretical component of the Clinical Research APM. It is expected to be a 1-day course.

Any times given or descriptions of activities within a course are given for guidance and as an example only. To establish whether a course is suitable, please compare this syllabus and the syllabus of a course on offer and take advice from your APM supervisor. Please also read our general guidance on ATSM courses.

The College can’t offer advice or information relating to the suitability of courses except for courses run by the RCOG or jointly run by the RCOG and specialist societies.

 

Course syllabus – lecture topics and timings

APM in Clinical Research (30 minutes)

  • Rationale for having this APM
  • Role of consultants in order to support clinical research service as an active participant
  • Explanation of theoretical and practical training, availability and certification

 

Clinical research in the NHS – organisational aspects (30 minutes)

  • Understanding local, regional and national research infrastructure
  • The role of the NIHR in Clinical Research in the UK
  • Stakeholders; University, NHS trusts, commercial organisations

 

Clinical Research Governance (1 hour)

  • Study applications, registration
  • Research Ethics applications and permissions
  • Research project approvals e.g. Research and Development, Clinical Trial Authority, Home Office, Caldicott Guardian, NIHR Portfolio Adoption
  • Understanding research legislation
  • Storage of Human Tissue
  • Data protection and patient data legislation
  • Funding organisations and sponsorship

 

Developing a research idea (30 mins)

  • Critical Appraisal of the Literature 
  • Developing, writing and reviewing a research protocol
  • Research study designs- clinical trials, cohort studies, controls, blind and double blind arrangements, cross over trials, etc

 

Essential training (30 mins)

  • The value of Good Clinical Practice (GCP) Training

 

Research methodology (30 mins)

  • Applied Statistics for Clinical Research
  • Epidemiological Methods in Medical research
  • Sampling techniques

 

Patient Participation in Clinical research (30 mins)

  • Recruitment
  • PPI

 

Disseminating Research (30 mins)

  • Research write-up: writing a grant proposal or a peer-reviewed paper
  • Preparing an oral or a poster presentation.
  • Correspondence/letters to Journals
  • Informing the public, social media

 

Research Integrity (30 mins)

  • Issues surrounding fraud/scientific misconduct
  • Awareness of complex dilemmas in scientific research
  • Plagiarism

 

Ending a study (30 Mins)

  • Responsibility for end of study procedures
  • Ethical, R&D, CTA requirements for end of study