| Date |
Session Topics |
Slides and Notes |
Wk 1
10 Jan |
Drug Discovery Process: Preclinical to IND to Clinical; The Players and their Roles: FDA, Sponsor(s), Clinical Sites, Investigators & Academic Health Centers: (D Hom) |
|
Wk 2
17 Jan |
Scientific Basis for a Clinical Trial: Epidemiology #1 (D Hom) |
|
Wk 3
24 Jan |
Scientific Basis for a Clinical Trial:
Epidemiology #2 (D Hom) |
|
Wk 4
31 Jan |
Human Subjects Protection: OHRP/federal regulations, Institutional Review Boards: (C Rodriguez)
NOTE: ROOM CHANGE: BERGEN BLDG. 3rd FLOOR, RM 330 |
|
Wk 5
7 Feb |
Clinical Phases: Phase I; Dose-finding: (D Hom) |
Color 2 Slides Per Page
B&W 3 Slides Per Page
B&W 6 Slides Per Page
Lilly Considers $1 Billion Fine to Settle Marketing Case
Access before Approval
FDA-1571
FDA-1572 |
Wk 6
14 Feb |
Clinical Phases: Phase IIa/IIb;Safety and Surrogate Efficacy: (D Hom) |
Color 2 Slides Per Page
B&W 2 Slides Per Page
B&W 6 Slides Per Page |
Wk 7
21 Feb |
Clinical Phases: Phase IIIa/IIIb; Large-scale Efficacy Trials – Part I: (D Hom) |
Color 2 Slides Per Page
B&W 3 Slides Per Page
B&W 6 Slides Per Page
F.D.A. Seeks to Broaden Range of Use for Drugs
NEJM 1984 - Physician's Reasons for not Entering Patients in a RCT |
Wk 8
28 Feb |
The Women’s Health Initiative (N Lasser)
NOTE: ROOM CHANGE: BERGEN BLDG. 3rd FLOOR, RM 330 |
Color 2 Slides Per Page
B&W 3 Slides Per Page
B&W 6 Slides Per Page
WHI PAPERS
WHI_Study_Summaries |
Wk 9
6 Mar |
Midterm Examination |
|
Wk 10
13 Mar |
Human Subjects Protection: Informed Consent: (C Rodriguez)
NOTE: ROOM CHANGE: BERGEN BLDG. 3rd FLOOR, RM 330 |
|
Wk 11
20 Mar |
Clinical Phases: Phase IIIa/IIIb efficacy trials; Hybrid Designs – Part II: (D Hom) |
|
Wk 12
27 Mar |
Protocol Conduct #1: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practices (GCP) Guidelines:
(C Rogers)
NOTE: ROOM CHANGE: BERGEN BLDG. 3rd FLOOR, RM 330 |
|
Wk 13
3 Apr |
Protocol Conduct #2: Recruitment strategies, Participant adherence, quality control and other site operations & the role of other orgs (CROs, SMOs, DCC), clinical site monitoring:
(C Rogers)
NOTE: ROOM CHANGE: BERGEN BLDG. 3rd FLOOR, RM 330 |
Color 2 Slides Per Page
B&W 2 Slides Per Page
B&W 3 Slides Per Page
B&W 6 Slides Per Page
Example of FDA Warning Letter
Eligibility Case Report Forms
Quality of Life Questionnaires
Source Documents
Source Eligibility Template
Source Templates
Typical Case Report Forms
Clinical Research Agreement
Confidentiality and Nondisclosure Agreement
Pre-Study Information Sheet
Addl Props from Protocol Conduct Presentation |
Wk 14
10 Apr |
Drug Discovery – Clinical Phases: Phase IV Post-marketing Surveillance and Studies: (D Hom) |
Color 2 Slides Per Page
B&W 2 Slides Per Page
B&W 3 Slides Per Page
B&W 6 Slides Per Page
FDA-3500
FDA-3500A |
| Wk 15 17 Apr |
Course Summary |
|
Wk 16
24 Apr |
Final Examination |
|
