HRTP Curriculum

All of our HRTP trainees complete a core curriculum that provides general skills that will be needed to embark on a career in clinical and translational pharmacology. Depending on the applicant and their prior training, supplemental coursework may be needed as prerequisites to these required core courses. On the other hand, individuals who have completed courses of similar content and intensity will be encouraged to identify supplemental courses that will complement their overall HRTP training program.

All trainees will be required to complete the online training programs offered through the Collaborative Institutional Training Initiative (CITI) for The Protection of Human Research Subjects and Responsible Conduct of Research (Biomedical Research Investigator focus). Trainees are encouraged to discuss this online training with their mentors. All trainees will receive instruction in the following areas:

·               Conflict of interest -- personal, professional, and financial

·               Policies regarding human subjects, live vertebrate animal subjects in research

·               Safe laboratory practices

·               Mentor and mentee responsibilities and relationships

·               Collaborative research including collaborations with industry

·               Peer review

·               Data acquisition and laboratory tools; management, sharing and ownership

·               Research misconduct and policies for handling misconduct

·               Responsible authorship and publication, including specific discussions regarding scientific writing practices, collaborative writing, publication practices, responsible authorship, the peer review process, conflicts of interest

·               The scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research

·               Compliance with regulatory requirements for clinical and translational research

Courses:

Course 1: International HIV Pharmacotherapy; Introductory
- Module 1: HIV/AIDS Pharmacotherapy HIV Certificate (Web based)
- Module 2: Introduction to Clinical Pharmacokinetics
- Module 3: Drug Interactions
- Module 4: Adverse Drug Reactions

Course 2: Pharmacology Laboratory Skills (Web based)
- Module 1: Introduction to Laboratory Quality Assurance and Quality Control

Course 3: Clinical Research
- Module 1: Human Subjects Protection (web based)
- Module 2: Ethics in HIV/AIDS Clinical Research
- Module 3: HIPAA
- Module 4: Biostatistics and Epidemiology
- Module 5: Clinical Research Methods

Course 4: Pharmacology Research Protocol
- Module 1: Research project Design and submission
- Module 2: Distribution

Course 5: PK/PD and Pharmacogenomics
- Module 1: ACTG Clinical Pharmacology Module
- Module 2: WINNONLIN Pharmacokinetics Primer
- Module 3: Pharmacogenomics Primer (One week)

Course 6: Scientific Writing
- Module 1: Literature search techniques
- Module 2: Proposal development and IRB submission completion
- Module 3: Abstracts, publication, and grants


Optional Modules
Applied Clinical Pharmacokinetics
Intermediate Pharmacokinetics
Advanced Pharmacokinetics


MODULE SUMMARIES

Course 1: International HIV Pharmacotherapy; Introductory

Module 1: HIV/AIDS Pharmacotherapy HIV Certificate (Web based)

Module 2: Introduction to Clinical Pharmacokinetics

Module 3: Drug Interactions

Module 4: Adverse Drug Reactions

Course 2:
Pharmacology Laboratory Skills (Web based)

Module 1: Introduction to Laboratory Quality Assurance and Quality Control

Course 3: Clinical Research

Module 1: Human Subjects Protection (web based)

Module 2: Ethics in HIV/AIDS Clinical Research
The module aims to provide a comprehensive introduction to the field of ethics of scientific research and satisfy all Federal requirements for education and exposure of graduate and post-doctoral students. The module explores the relationship between science and society with particular emphasis on the bioethical implications of contemporary genomic biological knowledge.

Module 3: HIPAA
UB HIPAA Training Tutorial and NIH Human Subjects Protection Tutorial
These tutorials are required for all AITRP trainees participating in clinical research projects. HIPAA tutorials outline changes and workplace effects trainees can expect because of HIPAA regulations.

Module 4: Biostatistics and Epidemiology
Introductory and advanced modules in HIV/AIDS statistics and epidemiological applications in HIV/AIDS research.

Module 5: Clinical Research Methods
This module prepares AITRP trainees for the process of clinical research in industry or academia. It provides a background of information on the clinical research process including: protocol development and implementation into study unit; ethics: informed consent and institutional review boards; clinical data acquisition and management; laboratory analysis of clinical specimens (with an emphasis on Good Laboratory Practices).

Course 4: Pharmacology Research Protocol

Module 1: Research project Design and submission

Module 2: Distribution

Course 5: PK/PD and Pharmacogenomics

Module 1: ACTG Clinical Pharmacology Module

Module 2: WINNONLIN Pharmacokinetics Primer

Module 3: Pharmacogenomics Primer (one week)
The module consists of lectures and in class exercises designed to introduce the principles and concepts in pharmacogenomics and pharmaceutical genetics. The module goal is to give students an understanding of the principles of human genetics and genomics such that they can then apply these skills to problems in therapy optimization and patient care.

Course 6: Scientific Writing

Module 1: Literature search techniques

Module 2: Proposal development and IRB submission completion

Module 3: Abstracts, publication, and grants


Optional Modules

Applied Clinical Pharmacokinetics:
The general goal of the module is to provide trainees with an introduction to the application of pharmacokinetic principles in pharmacy practice. The module involves trainees in the process of clinical pharmacokinetic and pharmacodynamic monitoring of drug therapy. The application of pharmacokinetics and pharmacodynamics to individualized drug dosage regimens in the clinical context, including such hepatic and renal functional impairment, other effects of disease, immaturity of drug metabolizing enzymes, and drug interactions are emphasized.

Intermediate Pharmacokinetics:
This module covers the theoretical development of the major methods, models and equations used in pharmacokinetics with their physicochemical and physiological assumptions and limitations. It employs the current graphical and computer methods of applying pharmacokinetics to analysis of experimental and clinical data; and it evaluates literature and approaches of design of studies and recovery of essential drug parameters.

Advanced Pharmacokinetics:
Rigorous theoretical development and application of kinetics and related mathematical and computer techniques to the study of drug absorption, distribution, metabolism, excretion presented at an advanced level.