SOP for Check in and check out of the Subject

OBJECTIVE

This SOP gives the procedure for check-in and check –out of subject, from the housing area before the start and the completion of the hospitalization period in a PK/PD studies.

SCOPE

This SOP is applicable to all volunteer/subjects participating in a PK/PD studies. All the PK/PD Should be preplanned and Make sure to avoid dosing schedules on Sundays (on Sunday Registration counter will be remains closed/Unavailability of the Study Nurses/PIs)

PROCEDURE

1. Procedure for Subject Check-In (in the First period of the study):

• The subjects who have given the written (signed) Informed Consent and have found eligible for the study in Screening, pre-enrollment checks and are complying with the inclusion and exclusion criteria’s as mentioned in the study protocol, and who are found negative in breath alcohol, Urine screen for drug of abuse and urine pregnancy test or any other screening procedure as mentioned in the study protocol will be checked-in into the private/Semi Private wards as per direction from the Medical Director.
• The Study coordinator/designated person will allot the subject number to each subject in ascending order (01 on wards) in first period of study or as specified in the respective study protocol on a first come first basis.
• Study coordinator/designated person/ Subject Custodian will check the subject’s belongings, clothing and pockets for any prohibited products like gum, medication, cigarettes and tobacco or sharp instruments.

2. Procedure for Check-In For Subsequent Period(s):

• The PI will perform the medical checks (history from the last visit), vital sign measurement and well being assessment, Clinical examination or any other investigation requirements as specified in the study protocol for the subject, before enrolling for subsequent Period of the study.
• Blood/urine samples will be collected and for testing in the Clinical laboratory as specified in the study protocol (if applicable).
• PI will review the above reports and will record the status of subject’s fitness in the CRF.
• If the subject is found to be eligible in all the above procedures, then he/she will be checkedin into the housing area as mentioned in point 1.
• The subject who is found to be unfit in any of the above parameters will be withdrawn from the study and will be checked-out as per the procedure mentioned in point 3.0. If the subjects have not reported to the study center for subsequent period or if the subject withdrew his/her consent from the study then the details of his/her withdrawal will be documented in the format for ‘Subject Dropout/Withdrawal /Termination Form’ of the CRF.

ALSO READ: SOP for Obtaining Informed Consent Form

3. Procedure for Check-Out

• Subject will be checked out after completion of the study /after completion of the housing period of each study period or due to withdrawal/termination of subjects from the study.
• In case subject is discharged after completion of the housing period of each study period or due to withdrawal/termination of the subjects from the study then the details will be recorded in the format ‘Discharge summary’ of the CRF of the respective subject.
• The Physician/designated person will measure the vital signs and assess the well being of subject and will perform the Clinical examination before discharge from the Clinical facility.

• The Subject Custodian/designated person will return the subjects belongings from the locker; will ensure that all the items provided by clinical facility are returned by the subject and also ensure that the subjects are informed about the schedule date and time of subsequent period or ambulatory sample (if applicable). The details of the check-out activity will be recorded in the form in the CRF.
• After completion of the study the Physician/designated person will perform the post study safety evaluation as mentioned in the study protocol.
• Physician/designated person will measure the vital sign, assess the well being of subject, take the 12 lead ECG, perform the Clinical examination and will record details in the ‘Post study evaluation form’ of the CRF of the respective subject.
• Physician and/or Clinical Investigator/Co-Investigator will check the ECG report of respective subject and will put the appropriate comment on the same after interpretation.
• As per the requirements of the protocol, the blood and /or urine samples for Post-study Clinical laboratory investigations will be collected and sent to the Clinical laboratory.
• The subject will be advised to contact the responsible person of the study center if any healthrelated problem arises after discharge from the study center. The details of the telephonic communication will be recorded in the ‘Telephonic communication and Subject follow-up form of the CRF.
• After receipt of Post-study Clinical laboratory investigation reports from the laboratory, it will be checked and reviewed by the Physician/designated person and the details of observation will be recorded in the Post study evaluation form of the CRF of the respective subject. The Physician/designated person will review the Post study Clinical laboratory report values with the base line (Screening report) values and determine its significance to judge if any Adverse Event has occurred/or any follow-up is required to resolve the same.
• If any significant abnormal results are found then the subject will be followed up to resolve the same and to ensure subject safety. The details will be recorded as adverse event in the CRF of the respective subject.

ANNEXURE

Nil

REVISION HISTORY

Nil

ALSO READ: SOP for Roles and Responsibilities of Clinical Research Coordinators