Standard Operating Procedures - SOP-18 - FRSQ
Standard Operating Procedures - SOP-18 - FRSQ
Standard Operating Procedures - SOP-18 - FRSQ
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<strong>Standard</strong> <strong>Operating</strong> <strong>Procedures</strong> (<strong>SOP</strong>)<strong>SOP</strong>-<strong>18</strong>Managing Investigational ProductsUnder Study
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Objectives– Define standard operating procedures which describe howinvestigational products are managed within theestablishment;– Provide basic standards in order to ensure compliance withapplicable regulatory requirements;– Ensure that procedures for management of research productsspecific to a sponsor/sponsor-investigator, are followed.
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Generalities– Responsibility for investigational products accountability at thestudy site rests with the investigator/institution• The investigational medications:– It is recommended to follow the same controls asmedications available by prescription
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Receipt and Inventory of Investigational Products– The investigator/qualified investigator, the pharmacist or theperson designated should:• Review the shipping instructions• Make an inventory of products received• List any product defectsRetain document with essential documentation
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Labelling and coding of Investigational Products– The sponsor/sponsor-investigator shall ensure that the drugbears a label on which appears information in both officiallanguages– A medical device for investigational testing should have alabel with the appropriate information
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Storage of Investigational Products– Secure environment– The investigator/qualified investigator, the pharmacist or theperson designated should :• Establish and maintain controlled access• Develop procedures to control access• Store investigational products in a locked room
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Distribution of Investigational Products– The investigator/qualified investigator, the pharmacist or theperson designated should:• Inform subject about the correct use of the investigationalproduct(s)
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Distribution of Investigational Products– Case of a study utilizing a drug:• Identify the person who is authorized to prescribe the drug• Document the assignment of the drug to the subject• Document any modification to or deviation from drugdosage• Submit to the Ethics Committee all significant deviationsfrom the drug dose/schedule that could have an impact onthe health of the subject
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Distribution of Investigational Products– Case of a study using an investigational device:• Specify the person who is authorized to prescribe theinvestigational device• Document the assignment of the investigational device tothe subject
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Accountability for Investigational Products– In the case of a study utilizing a drug, the investigator/qualifiedinvestigator, the pharmacist or the person designated should:• Document the quantity of drug used/returned for eachsubject• Compare the drug returned/used versus the allotted drug• Document any inconsistency• Under no circumstances, assign to another subject a drugassigned to a subject and not used• Retain documentation
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Accountability for Investigational Products– In the case of a study utilizing an investigational device, theinvestigator/qualified investigator, the pharmacist or theperson designated should:• Document return of the device• Under nor circumstances, assign to another subject adevice assigned to a subject and not used• Retain documentation
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under Study• Return/Destruction of Investigational Products– The investigator/qualified investigator, the pharmacist or theperson designated should:• Return to the sponsor/sponsor-investigator investigationalproducts or follow the instructions in the protocol• Ensure that the institution or the pharmacy has appropriateprocedures for destruction• Keep with the essential documentation
<strong>SOP</strong>-<strong>18</strong>Managing Investigational Products Under StudyQuestions ?
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