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Q: Educational Grant is a type of investigator Initiated Phase IV trials, funded by "A" company, which is either related ¡°A¡±-products or not related "A" products. Because it is an IIT, investigator(s) initiate and propose a study. If "A" is interested in the proposed study, "A" support the fund and "A" could comment on it. Other than these, the right and responsibility of the study are primarily on the investigator(s). We would like to ask KRPIA¡¯s opinion regarding our support on this type of phase IV study.
A: KRPIA Code ¹× Clinical Activity GuidelineÀº investigator sponsored study¸¦ ±× Àû¿ë´ë»ó¿¡¼ Á¦¿ÜÇÏ°í ÀÖ½À´Ï´Ù. µû¶ó¼, ȸ¿ø»ç´Â ÀÌ·¯ÇÑ ¿¬±¸ÀÇ ½ÃÇà¿©ºÎ¸¦ °øÁ¤°Å·¡¹ýÀÇ ÀÏ¹Ý ¿øÄ¢¿¡ µû¶ó °áÁ¤ÇÏ¿©¾ß Çϸç, µû¶ó¼, ÀÌ·¯ÇÑ ¿¬±¸Áö¿øÀÌ º¸°ÇÀÇ·áÀü¹®°¡ÀÇ Ã³¹æ¿¡ ¿µÇâÀ» ¹ÌÄ¥ ¸ñÀûÀÌ ÀÖ´ÂÁö ¿©ºÎ¿¡ µû¶ó Àû¹ý¼º ¿©ºÎ¸¦ ÆÇ´ÜÇÏ¿©¾ß ÇÒ °ÍÀÔ´Ï´Ù.