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Lectures5 E9 p1 i$ {7 Z* X
Print a copy of the Course Checklist (PDF document) to help you keep track of your progress in completing the Lectures and Exercises in the Good Practices in Clinical Research course.7 _; T! s( U. v1 J9 k! H2 A
View the lectures in the order listed. Your computer needs the free RealPlayer plug-in to access the lectures. For instructions on viewing the lectures and dealing with multiple windows, go to the Help Page.' ~. z5 b6 x* t1 Z/ u- Y3 N) ?
5 X4 C+ x1 p6 T0 d2 E* S
1. Clinical Research: An Overview
4 T" J# {' V: {4 d- Robert H. Rubin, MD
1 L! l- {6 N8 x% i' a1 l" Y2. Historical Development of International Regulations in Clinical Research5 o6 G; F1 a' M f/ r. _; F+ F
- Guillermo Rodríguez Gómez, MD8 l* D$ _7 r* \" }
3. Overview of the ICH GCP Guidelines2 I3 I& w5 n- [: O6 }
- Noemi Rosa, BS3 L6 b: ^1 Y: L/ h6 c1 y
4. The Institutional Review Board/The Ethics Committee
; ?2 o/ B _. u' b8 G1 T( y* V- Alan C. Moses, MD: U/ C4 k4 A& H5 x. t
5. Informed Consent 8 |+ q! m' ~2 M
- Robert H. Rubin, MD( n1 P2 Y& _/ s% L
6. Phases of Drug Development
5 U& ]" E* e4 B' x3 `" f- e$ P7 r- Honorio Silva, MD
! M" g7 D- H5 G, S! b' E/ [7. Clinical Trial Design/ ?5 b/ S* v% s! }+ X
- Guillermo Rodríguez Gómez, MD- S1 G* N- {/ [( W' O% q
8. Basic Concepts in Applied Statistics( ^1 `3 G# y0 E5 x( B
- Alan C. Moses, MD
' s% H$ @/ P* ]+ E* R+ Z# r9. Publishing Clinical Trial Results
: G d, S! _' ?: Z8 C- Robert H. Rubin, MD
6 A) y" [) u+ a+ |, }10. Evaluation of a Clinical Research Site
; F. R6 h( u* a/ w; |1 Y- Julio Camps, MD" L' r. C* R+ f% _) n* Y( ^/ X
11. The Protocol as a Clinical Research Tool( `& M- Z# T0 c+ c
- Pierre Etienne, MD- {- {7 k( \; O% Q
12. Trial Documents
6 }5 v4 M% X0 l9 A- Lillian Marinovich, BS Q- Q/ W; e E5 j
13. The Responsibilities of Conducting a Clinical Trial* K) b7 j5 _3 H" h- j; a
- Guillermo Rodríguez Gómez, MD; }6 d1 A/ |, h% f# m
14. Clinical Supplies Management [. M$ T6 b" f& h3 m* k
- Patrick Floody, BA
0 b" k1 N& T2 O, C! P+ s15. Safety Reporting Responsibilities
' Y( @ o0 i/ G; m0 }& a$ x6 G- Noemi Rosa, BS0 O( w2 l- \/ e3 H
16. Guidelines for CRF Completion: @! f* d ] o1 T9 {) H8 |0 j& p( j
- Brian Peters, BS
" f) o% u$ d! J17. Trial Monitoring
9 ?5 D3 B) n4 g6 X6 T& X* I- Ana María Valderrama, MD
3 K7 R5 h1 t! {4 ]( I) J18. Audit of a Clinical Trial Site
$ Y/ r' ?$ X& B- Barbara O'Neill, BS
8 M" D( ]7 E4 w+ V+ e19. Clinical Research in the 21st Century: Areas for Future Research; K2 P1 P; u- ^# L, F% @
- Robert H. Rubin, MD3 |' S" ]& ], N# r; i# O. U
20. ICIC: A Model of a Private Health Institution for Clinical Research1 Q5 T% d+ p& R+ V3 z4 g
- Guillermo Rodríguez Gómez, MD+ ~1 g& y9 [8 ?. Y
Interactive Exercises:, L/ _2 g ]5 r0 v5 K& [+ W5 r
Reviewing a Published Paper8 g8 V, D C5 u: G' ^# X; _
- Alan C. Moses, MD+ L4 Y. ~! V5 c, z9 q0 _
By doing this exercise, you will understand how the various elements in a paper work to communicate the authors' intentions, methods and results. In addition, you will also benefit from the guidance of an experienced reviewer, who will show you how to assess a paper's worth and give you the confidence to be a more discerning reader.
& S3 Y% j8 }+ X5 ]: S& g% ISafety Reporting Case Studies! q: F( K$ j, |; s
- Noemi Rosa, BS
0 @) v4 I0 A& B+ ~5 pThe purpose of this exercise is to help you learn to identify and report adverse events in medical situations. Before completing this exercise, please view Lecture 15, Safety Reporting Responsibilities.! ]+ v v! t/ ~9 f$ E% d
Closing Remarks0 T4 i2 j3 o! b9 O1 o. z
- Robert H. Rubin, MD- t3 P- l F" W) M# }) l# ~
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