MONITORING OF CLINICAL TRIALS ASSIGNMENT , TOPIC - " MAKE YOUR OWN SOP ON MONITORING PLAN " ( INCLUDES an example of a self-designed SOP Plan " )

1. MONITORING OF
CLINICAL TRIALS
ASSIGNMENT
TOPIC- “MAKE YOUR OWN SOP ON
MONITORING PLAN”

2. “WHAT IS A GOOD SOP
EXACTLY” ??

4. “ An Example of a self-designed SOP ”
ENTER COMPANY LOGO/ NAME :-
ENTER SOP CODE/VERSION No.-
PROJECT SPONSOR :-
1) DEPARTMENT:- ( ENTER NAME OF DEPARTMENT HERE)
2) DATE SOP WAS WRITTEN :- ( ENTER A DATE)
3) DATE SOP WAS APPROVED BY PI / LAB SUPERVISOR :- (
ENTER DATE OF APPROVAL )
4) PRINCIPAL INVESTIGATOR :- ( ENTER NAME OF PI )
5) INTERNAL LAB SAFETY COORDINATOR/ LAB MANAGER :-
(ENTER NAME )

5. 6) LAB PHONE NO. - (ENTER NO. )
7) ENTER OFFICE NO. :- ( ENTER OFFICE CONTACT NO. )
8) EMERGENCY CONTACT NO. :- (ENTER NO. )
9) LOCATION COVERED BY THIS SOP :- ( ENTER
BUILDING/ROOM NO. )
TYPE OF SOP : - MASTER SOP
PURPOSE :-
PHYSICAL AND CHEMICAL PROPERTIES/ DEFINITION OF
CHEMICAL GROUP :-

6. PERSONAL PROTECTIVE EQUIPMENT ISSUED :- ( IF ANY )
ENGINEERING CONTROLS :-
FIRST AID PROCEDURES :-
CODING OF QUALITY DOCUMENTS:-
LIST OF ESSENTIAL DOCUMENTS:-
LIST OF RELEATED DOCUMENTS :-
LIST OF RELEATED FORMS :-
NAME OF PROCEDURE :-
1) PRINCIPLE :-
2) PROCEDURE :-

7. SCOPE OF THIS SOP :- ( PROCESSES AND THEIR
RELEATION TO DEPARTMENTS )
TERMINOLOGY :- ( IF USED, ANY )
SUPPLEMENTARY INFORMATION :- ( LINKS,ADDITIONAL
RESOURCES , DOCUMENTS , etc)
METRICS :- ( INFO. OF METRIC UNITS USED )

8. APPLICABILITY OF THIS SOP :- ( RECRUITMENT OF
PARTICIPANTS FOR CLINICAL TRIALS )
TABLE OF CONTENTS :-
1) FASTER NAVIGATION TOOLS :-
2) PDF
3) INFORMATION
DEFINITIONS:-
HAZARD REDUCTION STRATEGIES AND RESOURCE
ISSUES :-

9. GOALS OF CLINICAL TRIALS :-
WORKING PRACTICE/ OPERATIONAL GUIDELINES :-
COMPANY POLICIES AND RULES:-

10. REFERENCES :-
https://tallyfy.com/standard-operating-procedure-sop/
https://www.iths.org/wp-content/uploads/ITHS-SOPs-for-Clinical-Research-03-03-10.pdf
https://www.google.com/search?q=an+example+of+a+Clinical+trial+SOP&rlz=1C1SQJL_enIN877IN877&sxsrf=ALeKk00Jou4EwPaHQjESRJ7l
XYjsvZ6K6w:1586792748054&source=lnms&tbm=isch&sa=X&ved=2ahUKEwjZtNHQ3-
XoAhVIWH0KHb7JBjAQ_AUoAnoECA0QBA&biw=1455&bih=688&dpr=1.1#imgrc=DYQu5kVF2Iy_qM
https://www.hey.nhs.uk/wp/wp-content/uploads/2016/03/SOP15.pdf
https://www.slideshare.net/rajeevkashyap/project-report-standard-operating-procedures

11. SUBMITTED TO :- DR. NILANJAN SAHA
MADE BY:- RISHABH SHARMA