GCP Guidance Policies and Templates
一组高级研究护士和研究协调员正在努力beplay苹果手机能用吗为临床试验管理制定标准操作程序，并根据良好的临床实践指南进行进行。此页面上共享的文档已由该组开发。包含的文件是：
- Guidance documents
- 标准作业程序
- Research Tools - templates, logs, checklists, worksheets, flowsheets
These documents are not meant to be prescriptive. The best way to use them would be to download them and edit them to suit your own study team's work flow.
If you would like to join this work group or if you have questions, comments and suggestions please contact us atclinicaltrials@uth.tmc.edu.
1.Developing and Maintaining Standard Operating ProceduresNEW
SOP模板NEW
2.Study Team Training and EducationNEW
3. Responsibilities of the Research Team
5.研究启动
Regulatory Binder Table of Contents Template
Case Report Form Templates(sample data collection forms, note to file sample language, regulatory binder document templates)
6.与CPHS通信
8.毒品问责制
Patient Returns Chain of Custody Form - MHH IDS
11.Study Completion Activities
12.准备检查
FDA Inspection Checklist
FDA Inspection Information
Subject Screening and Enrollment Log
17.Unanticipated Problems Involving Risks to Subjects or Others
18.协议偏差
21.词汇表
其他资源：
External Links:
FDA Regulations Relating to GCP and Clinical Trials
ADDITIONAL RESOURCES
CLINICAL RESEARCH UNITS (CRU)|伯德|REDCap
COMMITTEE FOR THE PROTECTION OF HUMAN SUBJECTS|ANIMAL RESEARCH|ENVIRONMENTAL HEALTH & SAFETY|CORE LABORATORIES|赞助项目|TECHNOLOGY MANAGEMENT
OFFICE OF RESEARCH
Clinical Trials Resource Center (CTRC)
7000 Fannin Street，Suite 795
德克萨斯州休斯顿77030
phone 713-500-3622
fax 713-500-0334
clinicaltrials@uth.tmc.edu