1.5.2.4 Principal investigators and study directors - Revision history

Bjoerngerlach at 12:54, 24 March 2021

2021-03-24T12:54:45Z

ChristophEmmerich at 19:47, 23 March 2021

2021-03-23T19:47:43Z

Bjoerngerlach at 12:35, 5 September 2020

2020-09-05T12:35:27Z

Bjoerngerlach: Created page with "== A. Background & Definitions == tba == B. Guidance & Expectations == * Enforces a climate of good scientific practice, rigor and reproduci..."

2020-09-01T12:23:47Z

Created page with "== A. Background & Definitions == tba == B. Guidance & Expectations == * Enforces a climate of good scientific practice, rigor and reproduci..."

New page

== A. Background & Definitions ==

tba

== 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 [[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.

* 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 ==

tba

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back to [[Toolbox]]

Next item: [[1.5.2.5 Research team]]

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 * 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 (experimental) plan]] 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 [[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.

@@ Line 6: / Line 6: @@
 * 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 (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.
+* Develops the [[2.1.1 Study (experimental) plan]] 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 plan, 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 protocol, the final report, raw data and supporting material are archived.

@@ Line 1: / Line 1: @@
 == 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 (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.
 * 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 ==
+to be added

1.5.2.4 Principal investigators and study directors - Revision history

Bjoerngerlach at 12:54, 24 March 2021

ChristophEmmerich at 19:47, 23 March 2021

Bjoerngerlach at 12:35, 5 September 2020

Bjoerngerlach: Created page with "== ​​​​​​​A. Background & Definitions == tba == ​B. Guidance & Expectations​ == ​* Enforces a climate of good scientific practice, rigor and reproduci..."

Bjoerngerlach: Created page with "== A. Background & Definitions == tba == B. Guidance & Expectations == * Enforces a climate of good scientific practice, rigor and reproduci..."