Author Topic: STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING  (Read 3153 times)

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Offline akshay_shah3000

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Hi,

I find this site very useful esp for fresher




http://researchcompliance.uc.edu/FDA/Research_SOPs2.html
STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING
ADMINISTRATIVE
ADM 001    
Writing and Revising Standard Operating Procedures
ADM 002    Change Control for Revising or Updating SOPs
ADM 003    Creation and Maintenance of Training Files
ADM 004    Clinical Research Personnel CVs and licenses
ADM 005    

Investigator CVs and licenses
   
MONITORING    
SOP Mon 001    Selection and Training of Monitors
SOP Mon 002    Pre-Qualification Monitoring Visit
SOP Mon 003    Site Initiation Visit
SOP Mon 004    Interim Monitoring Visit
SOP Mon 005    Close Out Monitoring Visit
   
FORMS    
Form 001    Monitor (CRA) Training Checklist
Form 002    Monitor Contact / Visit Sheet
Form 003    Pre Study Qualification Visit Report
Form 004    
Site Initiation Visit Report
Form 005    
Study Initiation Training Log
Form 006    Interim Visit Report
Form 007    Close Out Visit Report (no CRF to monitor)
Form 008    Close Out Visit Report (CRF to monitor)
Form 009    Sample Monitoring Visit Confirmation Letter
Form 010    Sample Monitoring Visit Follow-up Letter
Form 011    Documentation of Corrections at Site Form
Form 012    Telephone Log
Form 013    Adverse Event Tracking Log
Form 014    Informed Consent Checklist
Form 015    On Site Data Corrections Log
Form 016    Regulatory Submissions Tracking Form
Form 017    Subject Record Audit Form
Form 018    Sample Adverse Event Report
Form 019    Sample Financial Disclosure Form
Form 020    GCP Site Audit Report Form
   
APPENDIX    
Appendix 001    Guideline for the Monitoring of Clinical Investigations (from FDA)
Appendix 002    Sponsor Required Reports
Appendix 003    Guidelines: Case Report Form Completion
Appendix 004    Glossary of Common Clinical Research, Lay Terms and Acronyms
Appendix 005    Regulatory Documents Required
Appendix 006    Web Sites of Interest
Appendix 007    IRB Information Sheets – Frequently Asked Questions
Appendix 008    Regulatory Document QA
Appendix 009    GCP Site Audit Report Form Instructions
Appendix 010    Individual CRF Q Audit
Appendix 011    Belmont Report
Appendix 012    Declaration of Helsinki
Appendix 013    Nuremberg Code

Dr Akshay
CRA

Offline srikat

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Re: STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING
« Reply #1 on: January 24, 2009, 07:44 PM »
Awesome site Akshay... Very very useful. Thanks heaps!

Offline gmadiga

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Re: STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING
« Reply #2 on: January 25, 2009, 06:44 AM »
Hi akshay,

Thanks  a ton for the link. good one.

gm :) :)
“Research is to see what everybody else has seen, and to think what nobody else has thought” - Albert Szent, Nobel laureate for Medicine.

gmadiga

Offline anssu

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Re: STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING
« Reply #3 on: January 26, 2009, 09:44 AM »
Dear Akshay..
                  This is very gud one ...awesome...
                                                                    Thanks a ton
                                                                                      Anssu

Offline Sushma

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Re: STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING
« Reply #4 on: January 27, 2009, 02:36 AM »
Thanks for sharing Akshay,

Regards
Sushma
Sushma

"The secret to sucess is never to give up"

Offline karna chary

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Re: STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING
« Reply #5 on: January 27, 2009, 05:18 AM »
hi akshay

good work done by u.......

thnx n regards....... ;)  ;)
Karna Chary. A 
Clinical Research Associate.

Offline rockky_b

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Re: STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING
« Reply #6 on: January 27, 2009, 05:29 AM »
good Akshay nice site for SOP!
--
Thanks & Regards
ROcKKy

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"Words Can Hurt or Heal , What did yours do Today? "

Offline pritesh09

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Re: STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING
« Reply #7 on: January 27, 2009, 05:53 AM »
Dear Akshay,

Awesome  :) :)

Offline ramakrishna6d

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Re: STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING
« Reply #8 on: January 27, 2009, 06:40 AM »
Good work done ........
Thanks
Regards
Ramakrishna
I believe that a simple and unassuming manner of life is best for everyone, best both for the body and the mind

Offline karuna prasad devani

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Re: STANDARD OPERATING PROCEDURES FOR CLINICAL RESEARCH MONITORING
« Reply #9 on: January 27, 2009, 06:48 AM »
good work Akshay nice site for SOPs!


prasad

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