{"title":"临床试验研究项目管理-1","authors":"S. Alsuwaidan","doi":"10.35248/2167-0870.20.10.400","DOIUrl":null,"url":null,"abstract":"The scenario of this project came from amalgamation of both good clinical practice (GCP) the project management for professional (PMP); since all research studies and clinical trials are considered as research project then we have to prepare and formulate a “Research Manager” for research projects with specific job description for what are the steps to follow to get a successful and completed clinical trials. In-fact, writing this book depends on two main references articles namely: “A guide to the project management body of knowledge: (PMBOK guide)” project management for professional and “Clinical Trials Requirement Guideline (version 1.3)”, Drug sector, Saudi Food and Drug Authority, Kingdom of Saudi Arabia.","PeriodicalId":15375,"journal":{"name":"Journal of clinical trials","volume":"321 1","pages":"1-10"},"PeriodicalIF":0.0000,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Research Project Management on Clinical Trials-1\",\"authors\":\"S. Alsuwaidan\",\"doi\":\"10.35248/2167-0870.20.10.400\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"The scenario of this project came from amalgamation of both good clinical practice (GCP) the project management for professional (PMP); since all research studies and clinical trials are considered as research project then we have to prepare and formulate a “Research Manager” for research projects with specific job description for what are the steps to follow to get a successful and completed clinical trials. In-fact, writing this book depends on two main references articles namely: “A guide to the project management body of knowledge: (PMBOK guide)” project management for professional and “Clinical Trials Requirement Guideline (version 1.3)”, Drug sector, Saudi Food and Drug Authority, Kingdom of Saudi Arabia.\",\"PeriodicalId\":15375,\"journal\":{\"name\":\"Journal of clinical trials\",\"volume\":\"321 1\",\"pages\":\"1-10\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2020-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of clinical trials\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.35248/2167-0870.20.10.400\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of clinical trials","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.35248/2167-0870.20.10.400","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
The scenario of this project came from amalgamation of both good clinical practice (GCP) the project management for professional (PMP); since all research studies and clinical trials are considered as research project then we have to prepare and formulate a “Research Manager” for research projects with specific job description for what are the steps to follow to get a successful and completed clinical trials. In-fact, writing this book depends on two main references articles namely: “A guide to the project management body of knowledge: (PMBOK guide)” project management for professional and “Clinical Trials Requirement Guideline (version 1.3)”, Drug sector, Saudi Food and Drug Authority, Kingdom of Saudi Arabia.