MANAG ING BIOLOGICAL SAMPLES
Purpose
This SOP describes the procedures for collection. preparation, storage, and shipment of the biological sample.
Scope
This SOP will apply to all biological samples collected, processed stored, and shipped by SITE unless alternate directions are provided by the sponsor or Contract Research Organization (CRO).
Procedure
Collection of Samples
The study Nurse or the person delegated in the duty delegation log will collect the biological samples on scheduled visits as described in the protocol.
After collecting the sample, the study nurse or delegated person will record the details in the biological sample collection form
Preparation of Samples
Collection of Samples
The study Nurse or the person delegated in the duty delegation log will collect the biological samples on scheduled visits as described in the protocol.
After collecting the sample, the study nurse or delegated person will record the details in the biological sample collection form
Preparation of Samples
o The sample either is stored as collected and/or processed as mentioned in the protocol or laboratory manual provided by the sponsor /CRO.
• Using a permanent marker, the study nurse or CTC will record the patient initials patient ID, and the date and time when the sample was obtained on each sample label.
o In case of any damage to the sample or if the sample is unusable immediately inform to Sponsor/ CRO
(in case of sponsored study) and report deviation to IEC and document the same in the source note, if required.
Storage of Samples
• Before shipments, site personnel will store both urine and plasma samples at a temperature of at
At least - 20°C - or at a temperature mentioned in the protocol
• Other biological samples should be stored as mentioned in the protocol.
Shipment of Samples
Site personnel will
o Call the courier person as agreed by the sponsor/as mentioned in the protocol and schedule the date and time for shipping the sample.
o Inform the courier person 10 to bring the required materials for shipment as mentioned in the protocol.
o Complete all the biological sample inventory forms available in the collection kit listing all the samples in the shipment.
o Keep a photocopy of the Biological Sample Inventory page in the TMF.
Applicable Staff
This SOP applies to all the existing personals of the clinical research team and any new member appointed who may be responsible for study-related activities as mentioned in this SOP (per the delegation log). These include following
• Using a permanent marker, the study nurse or CTC will record the patient initials patient ID, and the date and time when the sample was obtained on each sample label.
o In case of any damage to the sample or if the sample is unusable immediately inform to Sponsor/ CRO
(in case of sponsored study) and report deviation to IEC and document the same in the source note, if required.
Storage of Samples
• Before shipments, site personnel will store both urine and plasma samples at a temperature of at
At least - 20°C - or at a temperature mentioned in the protocol
• Other biological samples should be stored as mentioned in the protocol.
Shipment of Samples
Site personnel will
o Call the courier person as agreed by the sponsor/as mentioned in the protocol and schedule the date and time for shipping the sample.
o Inform the courier person 10 to bring the required materials for shipment as mentioned in the protocol.
o Complete all the biological sample inventory forms available in the collection kit listing all the samples in the shipment.
o Keep a photocopy of the Biological Sample Inventory page in the TMF.
Applicable Staff
This SOP applies to all the existing personals of the clinical research team and any new member appointed who may be responsible for study-related activities as mentioned in this SOP (per the delegation log). These include following
- Research Trial (listed in the delegation log)
- Investigator
- Study Nurse
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3. STANDARD OPERATING PROCEDURE FOR COMMUNICATION WITH SPONSOR OR CONTRACT RESEARCH ORGANIZATION (CRO)
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