SOP for Dosing the Subject and Monitoring Restrictions

OBJECTIVE
This SOP gives the procedure for dosing the subjects and Monitoring Restrictions in compliance to the study Protocol for the Clinical study.

SCOPE
The SOP is applicable to PK/PD studies at the site XXX Ltd.
 

PROCEDURE
1. Monitoring Restriction 

• The Subject Custodian/designated person will be responsible for monitoring the compliance of diet, water, or any other restriction to be followed by the subjects in compliance to the Study protocol during the hospitalization period of the PK/PD study. 
• The Subject Custodian/designated person will monitor these restrictions and will record the details of the pre-dose and post-dose restriction compliance, in the Format for ‘Dosing and Restriction monitoring Record’ of the CRF of the respective subject. Any deviation will be documented in the CRF and will be justified appropriately. 

 

 

2. Dosing the subject 

• The dosing activity during the hospitalization period for Pharmacokinetic studies will be performed under the supervision of the Principal Investigator/ Co-Investigator. 
• The Principal Investigator /Co-Investigator will assign the responsibility of dosing to the trained staff.
• Staff responsible for dosing will ensure that gloves, dosing fluid (as per Protocol), flash light, tongue depressor, scissors (if applicable) and format ‘Dosing and Restriction monitoring Record’ for the subjects is kept ready on the dosing station well before scheduled time of dosing.
• The dose for each subject will be administered in a staggered manner to maintain subsequent blood collection schedule.
• The designated person will arrange the container containing the dispensed IP as per the subject number in the dosing station before initiation of dosing activity.
• The Subject Custodian will call subject by subject number for dosing prior to the scheduled time of dosing.
• The Designated person will give IP container of the respective subject to the respective staff dosing the subject in the dosing station.
• Staff responsible for dosing activity will verify the subject number and photo on ID card and the subject number on the label on the dispensed IP container before dosing.
• Staff responsible for dosing will assess the well being of the subject verbally before dosing, and will also briefly explain the procedure to be followed for dosing and the restriction to be followed thereafter. 
• Staff responsible for dosing activity will administer the IP directly in mouth of subject along with water/dosing fluid or as per the procedure mentioned in the respective study protocol at the scheduled dosing time for the respective subject. 
• Staff responsible for dosing activity will remove the duplicate label from the dispensed IP container and stick it on the ‘Dosing and Restriction monitoring Record’ of the CRF of the respective subject. 
• Staff responsible for dosing activity will store the empty IP container/syringe/ dosing cup/glass/tongue depressor used for the subject. 
• Staff responsible for dosing activity will record the actual time of dosing and dosing details in the ‘Dosing and Restriction monitoring Record’ of the CRF of the respective subject and will sign and date it. 

• The Clinical Investigator/Co-Investigator will verify the dosing activity and the compliance of the restrictions and will sign and date this record.
• The Designated person will collect unused IP(s) (due to subject dropout/terminated before dosing) and will take it to the IP storage room and will record in the IP accountability Record as per the respective SOP.
• In case of formulation where there is any specific requirement for administration/application of the IP the procedure for dosing/dose administration will be followed as per respective Study Protocol/Pack Insert/on the IP container.

ANNEXURE
Nil

REVISION HISTORY
Nil

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