Get the free PEDS-C STUDY DRUG COUNT FORM - NIDDK Central Repository - niddkrepository
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How to fill out peds-c study drug count
How to fill out peds-c study drug count:
01
Obtain the peds-c study drug count form from the designated source.
02
Start by entering the date at the top of the form to accurately record the drug count for that specific day.
03
Write down the name of the study drug(s) being administered or dispensed in the designated section of the form.
04
Record the quantity of each study drug available at the beginning of the day in the "Beginning Balance" column.
05
Throughout the day, carefully document the quantity of study drugs that have been dispensed or administered in the "Dispense" or "Administer" columns.
06
Track any study drugs that have been returned or wasted by entering the quantity in the appropriate column on the form.
07
At the end of the day, count the remaining quantity of study drugs on hand and enter this value in the "Ending Balance" column.
08
Calculate the "Total Dispensed" and "Total Wasted/Returned" values by subtracting the beginning balance from the ending balance, and adding or subtracting any dispensed or wasted/returned quantities respectively.
09
Sign and date the form to attest to its accuracy and completion.
Who needs peds-c study drug count:
01
Clinical researchers and investigators conducting pediatric clinical trials or studies require peds-c study drug count to accurately track and monitor the usage of study drugs.
02
Study nurses or study coordinators responsible for administering or dispensing study drugs to pediatric participants need peds-c study drug count to maintain detailed records of drug usage.
03
Regulatory authorities and ethics committees overseeing pediatric clinical trials may request peds-c study drug count as part of their monitoring and auditing processes.
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What is peds-c study drug count?
The peds-c study drug count is the number of investigational drugs being used in a Pediatric Exclusivity Study.
Who is required to file peds-c study drug count?
The sponsor of the Pediatric Exclusivity Study is required to file the peds-c study drug count.
How to fill out peds-c study drug count?
The peds-c study drug count can be filled out electronically through the appropriate regulatory agency's online portal.
What is the purpose of peds-c study drug count?
The purpose of the peds-c study drug count is to monitor the use of investigational drugs in Pediatric Exclusivity Studies.
What information must be reported on peds-c study drug count?
The peds-c study drug count must include the name and quantity of each investigational drug being used in the study.
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