- 1、本文档共6页,可阅读全部内容。
- 2、原创力文档(book118)网站文档一经付费(服务费),不意味着购买了该文档的版权,仅供个人/单位学习、研究之用,不得用于商业用途,未经授权,严禁复制、发行、汇编、翻译或者网络传播等,侵权必究。
- 3、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。如您付费,意味着您自己接受本站规则且自行承担风险,本站不退款、不进行额外附加服务;查看《如何避免下载的几个坑》。如果您已付费下载过本站文档,您可以点击 这里二次下载。
- 4、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等,请点击“版权申诉”(推荐),也可以打举报电话:400-050-0827(电话支持时间:9:00-18:30)。
- 5、该文档为VIP文档,如果想要下载,成为VIP会员后,下载免费。
- 6、成为VIP后,下载本文档将扣除1次下载权益。下载后,不支持退款、换文档。如有疑问请联系我们。
- 7、成为VIP后,您将拥有八大权益,权益包括:VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
- 8、VIP文档为合作方或网友上传,每下载1次, 网站将根据用户上传文档的质量评分、类型等,对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档
查看更多
組織研究計劃書
Taipei Medical University-Wan Fang Hospital
TITLE: Examples
Mechanisms of Resistance to Targeted Therapy with Imatinib in Patients with Leukemia
or
Breast Cancer Tissue and Clinical Data Repository for Identifying Molecular Markers of Clinical Outcome
Principal Investigator: Name
Address or Institution
Telephone
Co-Investigators: Name
Address or Institution
Telephone
Statistician: Name
(if applicable) Address or Institution
Telephone
Data Manager/: Name
Study Coordinator Address or Institution
Telephone
Initial Protocol Date: month/day/year
Protocol Revision Dates: month/day/year
TABLE OF CONTENTS
1. OBJECTIVES
2. BACKGROUND
Study Disease
Rationale
3. PATIENT or TISSUE SAMPLE SELECTION
Eligibility Criteria
4. METHODS
Source and Retention of Samples
Clinical Data Collection
Minimization of Risk and Protection of Confidentiality
5. LABORATORY PROCEDURES
6. STATISTICAL CONSIDERATIONS
Sample Size and Power
Methods
7. Ethical and REGULATORY REQUIREMENTS
Protocol Review
Informed Consent
OHSU Cancer Institute Data and Safety Monitoring Plan
Inclusion of Women, Minorities and Children
8. REFERENCES
APPENDIX A
Data Collection Forms
APPENDIX B
Informed Consent Form
1. OBJECTIVES
Insert primary protocol objectives.
Insert secondary protocol objectives, if pertinent.
For example:
1.1 To evaluate various tyrosine kinases for evidence of genomic and biochemical activation.
1.2 To test the effect of small molecule kinase inhibitors on the activation of wild-type and mutant tyrosine kinases.
To correlate tumor genotype and signaling abnormalities with clinical response to kinase inhibitors
1.4 Analysis of laboratory findings in relationship to patient demographics and clinical course.
2. BACKGROUND
Study Disease
Provide background information on the study disease.
Rationale
Provide the background and rationale for evaluating this tissue in this way.
For example:
Tyrosine kinases are expressed by many human cancers.1,2 These
文档评论(0)