½ÉÈ°úÁ¤ I
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ÀÇ·áÁ¤º¸º¸È£¹ý°ú Àӻ󿬱¸(HIPAA and Human Subjects Research)
ÀÓ»êºÎ ¹× ÅÂ¾Æ ´ë»ó ¿¬±¸(Research Involving Women of Childbearing Potential, Pregnant Women and Fetuses)
¾î¸°ÀÌ ´ë»ó ¿¬±¸(Research Involving Minors (45 CFR 46 Subpart D))
¼ö°¨ÀÚ ´ë»ó ¿¬±¸(Research Involving Prisoners)
ÇÇ°í¿ëÀÎ ´ë»ó ¿¬±¸(Workers as Research Subjects: A Vulnerable Population)
¹®ÈÀû/ÀÇÇÐÀûÀ¸·Î Ãë¾àÇÑ È¯°æÀÇ ÇÇÇèÀÚ±º ´ë»ó ¿¬±¸(Group Harms: Research with Culturally or Medically Vulnerable Groups)
À¯ÀüÇп¡¼ÀÇ Àӻ󿬱¸(Genetic Research in Human Populations)
½ÉÈ°úÁ¤ II
ÀÓ»ó½ÃÇè°ü¸®±âÁØ ÀÔ¹®(The CITI Good Clinical Practice Course: Instructions)
½Å¾à °³¹ß °úÁ¤ °³¿ä(Overview of New Drug Development)
ÀÓ»ó½ÃÇè Á¡°Ë ¹× ½ÇÅÂÁ¶»ç(Audits and Inspections in Clinical Trials)
±ÔÁ¤¿¡ µû¸¥ ¿¬±¸ÀÚ ÁÖµµÇü Àӻ󿬱¸ ¼öÇà(Conducting Investigator-Initiated Studies According to FDA Regulation)
½Ä¾àû Çã°¡ ¿¬±¸¿Í ½ÃÇèÀÚÀÇ Àǹ«(Investigator Obligations in FDA-Regulated Clinical Resea...rch)
½ÃÇèÀÚ¸¦ À§ÇÑ ±¹Á¦ÀÓ»ó½ÃÇèÅëÀÏȹæ¾È(International Conference on Harmonisation, ICH for Investigators)
±¹Á¦ÀÓ»ó½ÃÇèÅëÀÏȹæ¾ÈICH: ÀÓ»ó½ÃÇè °ü¸®±âÁØGCP ±ÔÁ¤(International Conference on Harmonisation(ICH): GCP Requirement)
½Ä¾àû Çã°¡ ´ë»ó ¿¬±¸(FDA Regulated Research)
ÇÇÇèÀÚ µ¿ÀǼ(Informed Consent)
ÀÇ·Ú±â°ü¿¡ ÀÇÇÑ ÀÓ»ó½ÃÇè ¸ð´ÏÅ͸µ(Monitoring of Clinical Trials by Industry Sponsors)
ÀÓ»ó½ÃÇè°ü¸®±âÁØ¿¡ µû¸¥ ÀÓ»ó½ÃÇè¿ë ÀǾàÇ° °ü¸®(Managing Investigational Agents According to GCP Requirements)
ÀÇ·á¿ë±â±âÀÇ ÀÓ»ó½ÃÇè(Conducting Clinical Trials of Medical Devices)
ÀÌ»ó ¹ÝÀÀÀÇ ¹ß°ß ¹× Æò°¡(Detection and Evaluation of adverse events)
Áß´ëÇÑ ÀÌ»ó ¹ÝÀÀ º¸°í(Reporting Serious Adverse Events)
CITI ½ÉÈ°úÁ¤ II¸¦ ¸¶Ä¡¸ç(Completing the CITI GCP Course)