Template protocol for Investigational Medicinal product(IMP)

More documents

Recommendations

Info

7.4INTERACTION WITH OTHER DRUGS7.5DISPENSING AND ACOUNTABILITY< Procedures for the pharmacy on dispensing and performing drug accountability should beincluded>8. DRUG SAFETY (Pharmacovigilance)The sponsor is responsible for the ongoing safety evaluation of the investigational product(s). Thesponsor should promptly notify all concerned investigator(s)/institution(s) and the competentauthorities (CAs) of finding(s) that could affect adversely the safety of subjects, (ICHGCP 5.16). TheSponsor should also follow ICHE2A (Guideline for Industry, Clinical Safety Data Management,Definitions and Standards for Expedited Reporting.8.1. DEFINITIONS (ICH E2A)Adverse Event or Adverse Experience(AE): Any untoward medical occurrence in a patient orclinical trial subject administered a pharmaceutical product and which does not necessarilyhave a causal relationship with this treatment.An AE therefore can be any unfavourable and unintended sign, symptom( including anabnormal laboratory finding), symptom, or disease temporally associated with the use of anInvestigational Medicinal Product (IMP), whether or not considered related to the IMP.Adverse Drug Reaction (ADR): In the pre-approval clinical experience with a new medicinalproduct or its new usages, particularly as the therapeutic dose(s) may need to beestablished.All noxious and unintended responses to a medicinal product related to any dose should beconsidered adverse drug reactions.The phrase “responses to a medicinal products” means a causal relationship between amedicinal product and an adverse event is at least a reasonable possibility i.e. therelationship cannot be ruled out. All AEs judged by either the reporting investigator or thesponsor as having a reasonable causal relationship to a medicinal product qualify as adversedrug reactions. The expression reasonable causal relationship means to convey in generalthat there is evidence or argument to support a causal relationship.Unexpected Adverse Drug Reaction (UAR): An adverse drug reaction , the nature andseverity of which is not consistent with the applicable product information (e.g.IB or SmPC)or is more severe than described in the IB or SmPC then this should be considered asunexpected e.g (a) acute renal failure in the IB/SmPC with a subsequent report ofinterstitial nephritis, (b) hepatitis with a first report of fulminant hepatitis.Serious Adverse Event (SAE) or Serious Adverse Reaction: Any untoward medicaloccurrence or effect that at any dose:Created by ICRIN (QM subgroup) . Version XX. Date:………. Page 8of 14
Results in DeathIs Life-threatening( Note: The term life-threatening in the definition of serious refers to an event inwhich the patient was at risk of death at the time of the event; it does not refer toan event which, hypothetically might have caused death if it was more severe)Requires hospitalisation or prolongation of hospitalisationResults in persistent or significant disability or incapacityIs a congenital anomaly or birth defectMedical judgement should be exercised in deciding whether expedited reporting is requiredin other situations, such as important medical events that may not be immediately lifethreateningor result in death or hospitalisation but may jeopardise the patient or mayrequire intervention to prevent the other outcomes listed in the definition above. Theseshould also be considered serious.Examples of such events are internsive treatment in an emergency room or at home forallergic bronchospasm, blood dyscrasias, or convulsions that do not result in hospitalisation;or development of drug dependency or drug abuse.Suspected Unexpected Serious Adverse Reaction (SUSAR): Any suspected adverse reactionrelated to an IMP that is both unexpected and serious. All require expedited reporting.8.2 CAUSALITYCausality assessment is required for clinical investigational cases, it is assumed in the case ofadverse event reports associated with marketed drugs.The causality assessment and assignment should be made by the investigator responsible forthe care of the subject using the definitions indicated below.RelationshipUnrelatedUnlikelyPossibleDescriptionThere is no evidence of a causal relationshipThere is little evidence to suggest there is a causal relationship( e.g the event did not occur within a reasonable time afteradministration of trial medication). There is anotherreasonable explanation for the event (e.g. concomitantmedications, clinical condition)There is some evidence to suggest a causal relationship (e.g.event occurs a reasonable time after administration of trialCreated by ICRIN (QM subgroup) . Version XX. Date:………. Page 9of 14
Page 6 and 7: 6El sitio de la American Family Phy
Page 10: medication, temporal relationship).

Template protocol for Investigational Medicinal product(IMP)

Create successful ePaper yourself

Delete template?

Save as template?