Difference between revisions of "1.5.2.4 Principal investigators and study directors"

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== ​​​​​​​A. Background & Definitions ==
 
== ​​​​​​​A. Background & Definitions ==
 
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== ​B. Guidance & Expectations​ ==
 
== ​B. Guidance & Expectations​ ==
 
 
​* Enforces a climate of good scientific practice, rigor and reproducibility, and continued excellence in preclinical data.  
 
​* Enforces a climate of good scientific practice, rigor and reproducibility, and continued excellence in preclinical data.  
 
 
* Establishes effective communication with research team and quality professionals (if present); enables training for research team so that approriate expertise is guaranteed to conduct with the appropriate quality needs​.​
 
* Establishes effective communication with research team and quality professionals (if present); enables training for research team so that approriate expertise is guaranteed to conduct with the appropriate quality needs​.​
 
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* Develops the [[2.1.1 Study protocol]] and ensures all procedures specified in the study protocol including amendments are followed and all data generated during a study are fully traceable and documented. Makes study protocol and amendments available to research team and quality professionals.
* Develops the [[Study (experimental) plan]] and ensures all procedures specified in the study plan including amendments are followed and all data generated during a study are fully traceable and documented. Makes study plans and amendments available to research team and quality professionals.
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* Ensure that all raw data generated are fully documented and recorded;  Signs and dates the final report to indicate acceptance of responsibility for the validity of the data; Ensures that, after completion of the study, the study protocol, the final report, raw data and supporting material are archived.​
 
 
* Ensure that all raw data generated are fully documented and recorded;  Signs and dates the final report to indicate acceptance of responsibility for the validity of the data; Ensures that, after completion of the study, the study plan, the final report, raw data and supporting material are archived.​
 
 
 
 
  
  
 
== ​C​. Resources ==
 
== ​C​. Resources ==
 
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Latest revision as of 12:54, 24 March 2021

​​​​​​​A. Background & Definitions

to be added


​B. Guidance & Expectations​

​* Enforces a climate of good scientific practice, rigor and reproducibility, and continued excellence in preclinical data.

  • Establishes effective communication with research team and quality professionals (if present); enables training for research team so that approriate expertise is guaranteed to conduct with the appropriate quality needs​.​
  • Develops the 2.1.1 Study protocol and ensures all procedures specified in the study protocol including amendments are followed and all data generated during a study are fully traceable and documented. Makes study protocol and amendments available to research team and quality professionals.
  • Ensure that all raw data generated are fully documented and recorded; Signs and dates the final report to indicate acceptance of responsibility for the validity of the data; Ensures that, after completion of the study, the study protocol, the final report, raw data and supporting material are archived.​


​C​. Resources

to be added​



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