24-WEEK TRAINING REGISTRATION
AFTER COMPLETING 2-DAY OR 3-DAY GCP TRAINING PROGRAM
Research teams (individuals) that have completed the Research Investigators Institute (DOMESTIC/USA or INTERNATIONAL) may apply for placement in the 24-week advanced training program.
Please complete the on-line registration form. Provide your name, e-mail address, website for your affiliated institution (HOMEPAGE), the country that you will be conducting clinical trials (IN WHERE ARE YOU FROM?), and name of the institution/hospital (COMMENTS)
2 4 - W e e k C o m p r e h e n s i v e T r a i n i n g
This 11 course-training program includes regulatory training, disease-specific
training, clinical trials management, clinical research program development,
CV/Résumé design, and preparation for future clinical research certification.
F u n d a m e n t a l s o f C l i n i c a l R e s e a r c h
Course Number: SEP 100 Contact Hours: 15.0 Continuing Education Units: 1.5 CEU
F u n d a m e n t a l s o f C l i n i c a l R e g u l a t i o n s
Course Number: SEP 110 Contact Hours: 15.0 Continuing Education Units: 1.5 CEU
E s s e n t i a l s f o r D e v e l o p i n g a C l i n i c a l
R e s e a r c h P r o g r a m
Course Number: SEP 120 Contact Hours: 15.0 Continuing Education Units: 1.5 CEU
CCTSA – LEVEL 2
C L INI C A L T R IA L S F O UND A T I O N S & R E G U L A T O R Y A S S E S SMEN T
Contact Hours: 0.0 Continuing Education Units: 0.0 CEU
A C A D E M I C C L I N I C A L D A T A M A N A G E M E N T
Course Number: SEP 200 Contact Hours: 15.0 Continuing Education Units: 1.5 CEU
I N T R O D U C T I O N T O C L I N I C A L M O N I T O R I N G
Course Number: SEP 210 Contact Hours: 15.0 Continuing Education Units: 1.5 CEU
INTRODUCTION TO CLINICAL COORDINATION
Course Number: SEP 220 Contact Hours: 15.0 Continuing Education Units: 1.5 CEU
CCTSA – LEVEL 3
A P P L I E D C L I N I C A L T R I A L S M A N A G E M E N T A S S E S S M E N T
D E V E L O P I N G A I C M R C O M P L I A N T C L I N I C A L R E S E A R C H P R O G R A M
Course Number: SEP 300 Contact Hours: 15.0 Continuing Education Units: 1.5 CEU
I N S T I T U T I O N A L R E V I E W B O A R D ( I R B ) / E T H I C S C O M M I T T E E ( E C ) : I D E N -
T I F I C A T I O N O F P R O V I D E R S , S E R V I C E S , A N D T H E C L I N I C A L S I T E P A C K A G E
Course Number: SEP 310 Contact Hours: 15.0 Continuing Education Units: 1.5 CEU
ESSENTIALS OF DEVELOPING DISEASE SPECIFIC TRAINING
Course Number: SEP 500 Contact Hours: 15.0 Continuing Education Units: 1.5 CEU
CCTSA – LEVEL 4
A D V A N C E D C L I N I C A L T R I A L S O P E R A T I O N S A S -
S E S S M E N T
Week 25: Monday (Reading Day) Due Date: Wednesday (Week 25)
Contact Hours: 0.0 Continuing Education Units: 0.0 CEU
The Level 4 assessment occurs after week 24. Sephmer Clinical must receive the Level 4 assessment by Monday at 12:00 noon EST (USA). Assessment will be evaluated and a testing report will be provided to the designated Principal Investigator.
Clinicians-students will receive an individual report indicating course areas that may need to be re-assessed or course may have to be retaken. This is the final assessment for the program.