E-mail: contact@sasonlinetrainings.comContact Person : BaluIndia : +91-9966956770+91-9966946199USA: +1 (551) 226-6061
Clinical Trial ProcessOverviewByNaidusasonlinetrainings.comContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (5...
What Is SAS? SAS-Statistical analysis software/System Developed in the early 1970s at North CarolinaState University.Or...
What Is a Clinical Trial? Effectiveness of intervention to treat adisease Safety of a new drug or device Defining dose ...
Clinical Research ProcessApproved protocol Investigator selection Approval ProcessPatientRecruitmentData Entry & Validatio...
Types of Clinical Trials Treatment– Test new approaches to treat a disease Prevention– What approaches can prevent disea...
Clinical Trails – OverviewChemistrySynthesis PurificationFormulationAnimalPharmacologyAnimal ToxicityAsses Safety &Biologi...
Phases of Drug DevelopmentPhase 1 Phase 2 Phase 3 Phase 4No. ofParticipants15-30 100-300 100 tothousandsSeveralhundreds to...
Who are the Players? Human Subject Volunteers Physician Investigators & Staff NIH – National Institutes for Health Man...
Why is Human Research HighlyRegulated? Past transgressions lead to the need for lawsthat protect the rights and welfare o...
Evolution of Regulations 1938 – Food, Drug & Cosmetic ACT 1962 – Kefauver-Harris Amendment 1968 – Drug Efficacy Study I...
Declaration of Helsinki World Medical Association June 1964(Helsinki, Finland) Forms the basis of ICH-GCP Covers all “m...
Human Research is HighlyRegulated Code of Federal Regulations (CFR)– Title 21- Food and Drugs» Part 50 Informed Consent» ...
What About InternationalRegulation?ICH definition – GCP “A standard for the design, conduct, performance,monitoring, aud...
ICH-GCP ICH is the International Conference onHarmonisation of Technical Requirementsfor Registration of Pharmaceuticals ...
The Objectives of ICH GCPGuidelines Developed with consideration of the current good clinicalpractices of the European Un...
Good Clinical Practice - GCP What is GCP?– Ethical and scientific quality standards fordesigning, conducting, recording a...
ICH GCP Guidelines cover…Investigator’sBrochureInvestigator
Research Protocol: Roadmap Detailed Research Plan that Includes:– Objectives– Background and Rationale– Subject Selection...
Protocols A Phase I, Double-blind, Placebo-controlled, Dose-escalation Study of theSafety and Pharmacokinetics of Drug A3...
Protocol Mouthful A PHASE 1, RANDOMIZED, PLACEBO-CONTROLLED, SEQUENTIAL PARALLELGROUP, MULTIPLE DOSE ESCALATIONTRIAL TO E...
Study Flow Chart
Study Flow Chart
Institutional Review Board(IRB) All clinical trials must be approved andmonitored by an IRB. IRB is an independent commi...
What is Informed Consent?"Informed consent is a process by which a subjectvoluntarily confirms his or her willingness topa...
Informed Consent Learning the key facts about a trial beforedeciding whether to participate.– Research study purpose– Ris...
Patient Recruitment Challenge Poor patient recruitment is the number onereason that trials fail. Only 3 to 5 percent of ...
Recruitment Strategies Physician trust and contact Study staff contact Speaking to community groups Newspaper and radi...
Safety Data collected in ClinicalTrials Adverse Events Serious Adverse Events Adverse Reactions Suspected Unexpected S...
Safety Data collected in ClinicalTrials Data is collected on case report forms(CRF) Much of clinical data is taken from ...
Done in excel using a blank CRF template provided byOpenclinicaDesigning CRFsContact : Balu India : +91-9966956770 +91-996...
Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sas...
The excel sheet is then uploaded onto OpenClinicaUploading CRFsContact : Balu India : +91-9966956770 +91-9966946199 USA: +...
Event DefinitionContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-ma...
Data EntryContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : c...
Data ExtractionContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mai...
System End of OpenClinica
 Backups implemented via a scheduled commandrunning as a batch file that writes out the data andmetadata for each of the ...
Clinical Data ManagementProtocol CRF Design DB DesignDBValidationDatabaseReport Data AnalysisContact : Balu India : +91-99...
Data AnalysisDatabase Extraction SAS TablesContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www....
An Adverse Event (AE) is… Any untoward medical occurrence Not necessarily causal relationship withtreatment Unfavourabl...
A Serious Adverse Event (SAE) is an AE that… Results in death Is life threatening Requires hospitalisation or prolongat...
SAE definitions Results in death– Record the event that lead to death as the SAE– “Death” is the outcome Life threatenin...
SAE definitions Prolonged hospitalisation- Record diagnosis NOT procedure- Hospitalisation means in-patientadmission- Not...
SAE definitions Prolonged hospitalisation– Record diagnosis NOT procedure– Hospitalisation means in-patient admission– No...
SAE definitions Congenital anomaly– Diagnosed in the offspring of a subject whoreceived study drug Other– Additional opt...
A Suspected Adverse Reaction (SAR)is… Untoward or unintended response to themedicinal product under investigationContact ...
A Suspected Unexpected Serious Adverse Reaction(SUSAR) is… A serious adverse reaction Unexpected-not consistent with inf...
Adverse event reporting Will depend upon the trial and be defined in theprotocol Generally any AE or SAR should be recor...
Introduction to MedDRA(Medical Dictionaryfor Regulatory Activities)Contact : Balu India : +91-9966956770 +91-9966946199 US...
What is MedDRA?Med = MedicalD = Dictionary forR = RegulatoryA = ActivitiesContact : Balu India : +91-9966956770 +91-996694...
Objectives for MedDRA Development An international multi-lingual terminology Standardized communication betweenindustry ...
Objectives for MedDRA Development(cont) Classification for a wide range of clinicalinformation Support for multiple medi...
MedDRA DefinitionMedDRA is a clinically-validated internationalmedical terminology used by regulatoryauthorities and the r...
MedDRA HierarchySystem Organ Class (SOC)High Level Group Term (HLGT)High Level Term (HLT)Preferred Term (PT)Lowest Level T...
System Organ Classes• Blood and lymphatic system disorders• Cardiac disorders• Congenital, familial and genetic disorders•...
 Each MedDRA term assigned an 8-digitnumeric code The code is non-expressive Codes can fulfill a data field in variouse...
 Terms are being renamed– When terms are renamed, the code number isreused for the renamed term– Renaming has been done f...
Non-Current Terms Non-current terms are flagged at the LLTlevel within MedDRA Not recommended for continued use Retaine...
A Multi-Axial TerminologyMulti-axial = the representation of a medicalconcept in multiple SOCs Allows terms to be grouped...
SOC = Respiratory, thoracic andmediastinal disordersHLGT = Respiratory tractinfectionsHLT =Viral upper respiratorytract in...
PT = Diabetes mellitusHLT = Diabetes mellitus (incl subtypes)HLGT = Glucose metabolism disorders (incl diabetes mellitus)A...
What’s New for MedDRAVersion 15.1 MedDRA Version 15.1 was made availableto subscribers on 1 September 2012Contact : Balu ...
Clinical Trial End Product Ideal: Unambiguous conclusion regardingthe clinical outcome of the testtreatment/device. Alwa...
Thank You ….Any Questions ?
Today’s AssignmentVisit www.sas.com to know more about SASContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (55...
Please Visit……www.sasonlinetrainings.comAddress :SAS onlineTraining CenterNear Cyber Towers, Hitech CityHyderabad. Pin -50...
Clinical sas training overview
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Clinical sas training overview

  1. 1. E-mail: contact@sasonlinetrainings.comContact Person : BaluIndia : +91-9966956770+91-9966946199USA: +1 (551) 226-6061
  2. 2. Clinical Trial ProcessOverviewByNaidusasonlinetrainings.comContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  3. 3. What Is SAS? SAS-Statistical analysis software/System Developed in the early 1970s at North CarolinaState University.Originally intended for management and analysis ofagricultural field experiments. Now the most widely used statistical softwareCEO-Jim Gudnight (Founder of SAS institute)Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  4. 4. What Is a Clinical Trial? Effectiveness of intervention to treat adisease Safety of a new drug or device Defining dose administration Testing drug formulation Exploring combination therapies Evaluating effect of therapies on quality oflifeContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  5. 5. Clinical Research ProcessApproved protocol Investigator selection Approval ProcessPatientRecruitmentData Entry & ValidationDataAnalysisPresentation to Steering committee Submission for FDA/DCGI
  6. 6. Types of Clinical Trials Treatment– Test new approaches to treat a disease Prevention– What approaches can prevent disease Early-detection/screening– What are new ways to find hidden disease Diagnostic– How can new tests or procedures ID diseaseContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  7. 7. Clinical Trails – OverviewChemistrySynthesis PurificationFormulationAnimalPharmacologyAnimal ToxicityAsses Safety &Biological activity inAnimalsPHASE – IDetermineSafety &DosagePHASE – IIEvaluateEfficacy, lookfor sideeffectsPHASE- IIICompare newagent withstandardtreatmentSafetyFDA /DCGIPHASE IVAdditionalpostmarketingtestingrequired byFDAPre-clinical Development Clinical TrailsAccelerated Development / ReviewIND5000 compoundsevaluated5 enter trails 1 approved – SUCCESS RATEFile IND atFDA / DCGIFile NDA atFDA / DCGI3-4 YEARS 6 YEARS 2 YEARS
  8. 8. Phases of Drug DevelopmentPhase 1 Phase 2 Phase 3 Phase 4No. ofParticipants15-30 100-300 100 tothousandsSeveralhundreds toseveralthousandsPurpose First inhumanssafe dosePOC1/3 failDetermineefficacySafety50% failComparenew agentwith standardtreatmentSafety1/3 failPost –marketLong-termsafety andefficacyContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  9. 9. Who are the Players? Human Subject Volunteers Physician Investigators & Staff NIH – National Institutes for Health Manufacturing companies (Sponsor) OHRP - Office for Human Research Protections FDA – Food & Drug Administration (CDER, CBER, CDRH) Settings: Academic, Private Practice, ProfessionalContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  10. 10. Why is Human Research HighlyRegulated? Past transgressions lead to the need for lawsthat protect the rights and welfare of humansubjects.– Nuremberg Doctors Trial of 1946 (Nuremberg Code)– Thalidomide Tragedy (Kefauver-Harris Amendment)– Tuskegee Experiments (Belmont Report)– Human Radiation Experiments– Gene Transfer ExperimentContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  11. 11. Evolution of Regulations 1938 – Food, Drug & Cosmetic ACT 1962 – Kefauver-Harris Amendment 1968 – Drug Efficacy Study Implementation 1981 – IRB Review Required 1983 – Orphan Drug Act 1997 – ICH-E6 Good Clinical Practice (GCP) 1998 – Pediatric Rule 2000 – NIH launches www.clinicaltrials.govContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  12. 12. Declaration of Helsinki World Medical Association June 1964(Helsinki, Finland) Forms the basis of ICH-GCP Covers all “medical research” Most recent amendment October 2000Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  13. 13. Human Research is HighlyRegulated Code of Federal Regulations (CFR)– Title 21- Food and Drugs» Part 50 Informed Consent» Part 56 IRB» Part 312 IND» Part 314 NDA» Part 600, 6001 Biologics» Part 812, 813, 814 Medical Devices– Title 45- Public Welfare» Part 46 (subparts B, C, D) DHHS, Protection of Human subjectsContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  14. 14. What About InternationalRegulation?ICH definition – GCP “A standard for the design, conduct, performance,monitoring, auditing, recording, analyses, andreporting of clinical trials that provides assurancethat the data and reported results are credible andaccurate, and that the rights, integrity, andconfidentiality of trial subjects are protected”Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  15. 15. ICH-GCP ICH is the International Conference onHarmonisation of Technical Requirementsfor Registration of Pharmaceuticals forHuman Use ICH-GCP is Good Clinical Practiceguidelines agreed at the conferenceContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  16. 16. The Objectives of ICH GCPGuidelines Developed with consideration of the current good clinicalpractices of the European Union, Japan & USA, plus those ofAustralia, Canada, the Nordic countries & World HealthOrganisation. Provide a unified standard for the European Union, Japan &USA to facilitate the mutual acceptance of clinical data by theregulatory authorities in these jurisdictions.Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  17. 17. Good Clinical Practice - GCP What is GCP?– Ethical and scientific quality standards fordesigning, conducting, recording and reportingtrials that involve participation of humansubjects Why is it needed?– To ensure that the RIGHTS, SAFETY andWELLBEING of the trial subjects are protected– Ensure the CREDIBILITY of clinical trial dataContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  18. 18. ICH GCP Guidelines cover…Investigator’sBrochureInvestigator
  19. 19. Research Protocol: Roadmap Detailed Research Plan that Includes:– Objectives– Background and Rationale– Subject Selection Criteria– Treatment Plan– Study Procedures– Response Evaluation Criteria– Statistical SectionContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  20. 20. Protocols A Phase I, Double-blind, Placebo-controlled, Dose-escalation Study of theSafety and Pharmacokinetics of Drug A31in Subjects with Type 2 Diabetes Mellitus A randomized, double-blind, placebo-controlled study assessing the effect of(study drug) Controlled-Release Tablet onhypoglycemia in type 1 diabetic subjectsintensively treated with insulinContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  21. 21. Protocol Mouthful A PHASE 1, RANDOMIZED, PLACEBO-CONTROLLED, SEQUENTIAL PARALLELGROUP, MULTIPLE DOSE ESCALATIONTRIAL TO EVALUATE THE SAFETY,TOLERABILITY, PHARMACOKINETICS,AND PHARMACODYNAMICS OF 28 DAYSOF ADMINISTRATION OF ND- 00254TABLETS TO SUBJECTS WITH TYPE 2DIABETES MELLITUSContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  22. 22. Study Flow Chart
  23. 23. Study Flow Chart
  24. 24. Institutional Review Board(IRB) All clinical trials must be approved andmonitored by an IRB. IRB is an independent committee ofphysicians, nurses, statisticians, communityadvocates and others. The function of the IRB is to ensure that aclinical trial is ethical and the rights welfareof study participants are protected.Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  25. 25. What is Informed Consent?"Informed consent is a process by which a subjectvoluntarily confirms his or her willingness toparticipate in a particular clinical trial, after havingbeen informed of all aspects of the trial that arerelevant to the subjects decision to participate”Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  26. 26. Informed Consent Learning the key facts about a trial beforedeciding whether to participate.– Research study purpose– Risks/Benefits– Alternative treatments– Confidentiality of records– Medical treatment available if injury occurs– Whom to contact for answers to questions– Statement that participation is voluntaryContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  27. 27. Patient Recruitment Challenge Poor patient recruitment is the number onereason that trials fail. Only 3 to 5 percent of newly diagnosedadult cancer patients participate in a clinicaltrial. Reasons for this relatively low number aremany.Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  28. 28. Recruitment Strategies Physician trust and contact Study staff contact Speaking to community groups Newspaper and radio Ads Internet websites Physician referralsContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  29. 29. Safety Data collected in ClinicalTrials Adverse Events Serious Adverse Events Adverse Reactions Suspected Unexpected Serious AdverseReaction Pregnancy Lab data Vital Signs Project specific data
  30. 30. Safety Data collected in ClinicalTrials Data is collected on case report forms(CRF) Much of clinical data is taken from thesubjects medical record (source documents) Pharmaceutical and device trials, data isverified by multiple playersContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  31. 31. Done in excel using a blank CRF template provided byOpenclinicaDesigning CRFsContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  32. 32. Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  33. 33. The excel sheet is then uploaded onto OpenClinicaUploading CRFsContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  34. 34. Event DefinitionContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  35. 35. Data EntryContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  36. 36. Data ExtractionContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  37. 37. System End of OpenClinica
  38. 38.  Backups implemented via a scheduled commandrunning as a batch file that writes out the data andmetadata for each of the studies databases addingTimestamp information to the filename.Pg Dump utility Creates a backup file onthe secondary HDD on the main server.File automatically copied to NAS1NAS1DatabaseDatabaseserverThe Back Up SettingContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  39. 39. Clinical Data ManagementProtocol CRF Design DB DesignDBValidationDatabaseReport Data AnalysisContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  40. 40. Data AnalysisDatabase Extraction SAS TablesContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  41. 41. An Adverse Event (AE) is… Any untoward medical occurrence Not necessarily causal relationship withtreatment Unfavourable /unintended sign
  42. 42. A Serious Adverse Event (SAE) is an AE that… Results in death Is life threatening Requires hospitalisation or prolongation ofstay Results in persistent or significantdisability/incapacity
  43. 43. SAE definitions Results in death– Record the event that lead to death as the SAE– “Death” is the outcome Life threatening– “The patient was, in the view of theinvestigator, at immediate risk of death fromthe event as it occurred. It does not include anevent that, had it occurred in a more seriousform, might have caused death”Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  44. 44. SAE definitions Prolonged hospitalisation- Record diagnosis NOT procedure- Hospitalisation means in-patientadmission- Not out-patient appointments or EDvisits Disabling or incapacitating- Event which is disabling or
  45. 45. SAE definitions Prolonged hospitalisation– Record diagnosis NOT procedure– Hospitalisation means in-patient admission– Not out-patient appointments or ED visits Disabling or incapacitating– Event which is disabling or incapacitating orcauses a disruption of one’s ability to carry outnormal life functions or daily activitiesContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  46. 46. SAE definitions Congenital anomaly– Diagnosed in the offspring of a subject whoreceived study drug Other– Additional option given by somepharmaceutical companies– Event not covered by SAE categories but in theinvestigator’s opinion, should be consideredseriousContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  47. 47. A Suspected Adverse Reaction (SAR)is… Untoward or unintended response to themedicinal product under investigationContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  48. 48. A Suspected Unexpected Serious Adverse Reaction(SUSAR) is… A serious adverse reaction Unexpected-not consistent with informationalready available in the protocol and theInvestigators BrochureContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  49. 49. Adverse event reporting Will depend upon the trial and be defined in theprotocol Generally any AE or SAR should be recorded in thepatient notes and Case Report Form and reported tothe Principal Investigator (PI) at the study site The PI determines whether the AE or SAR is serious The PI informs the Chief Investigator (multicentrestudies) of any SAE or SUSAR The Chief Investigator will report any SAE or SUSARto the Trial Sponsor, Data Monitoring Committee,MHRA and/or Ethics Committee, as specified in theprotocol
  50. 50. Introduction to MedDRA(Medical Dictionaryfor Regulatory Activities)Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  51. 51. What is MedDRA?Med = MedicalD = Dictionary forR = RegulatoryA = ActivitiesContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  52. 52. Objectives for MedDRA Development An international multi-lingual terminology Standardized communication betweenindustry and regulators Support of electronic submissions Application through all phases of thedevelopment cycleTo provide:Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  53. 53. Objectives for MedDRA Development(cont) Classification for a wide range of clinicalinformation Support for multiple medical product areas A terminology that saves time, resources,and moneyTo provide (cont):Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  54. 54. MedDRA DefinitionMedDRA is a clinically-validated internationalmedical terminology used by regulatoryauthorities and the regulated biopharmaceuticalindustry. The terminology is used through theentire regulatory process, from pre-marketingto post-marketing, and for data entry, retrieval,evaluation, and presentation.Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  55. 55. MedDRA HierarchySystem Organ Class (SOC)High Level Group Term (HLGT)High Level Term (HLT)Preferred Term (PT)Lowest Level Term (LLT)
  56. 56. System Organ Classes• Blood and lymphatic system disorders• Cardiac disorders• Congenital, familial and genetic disorders• Ear and labyrinth disorders• Endocrine disorders• Eye disorders• Gastrointestinal disorders• General disorders and administration siteconditions• Hepatobiliary disorders• Immune system disorders• Infections and infestations• Injury, poisoning and proceduralcomplications• Investigations• Metabolism and nutrition disorders• Musculoskeletal and connective tissuedisorders• Neoplasms benign, malignant and unspecified(incl cysts and polyps)• Nervous system disorders• Pregnancy, puerperium and perinatalconditions• Psychiatric disorders• Renal and urinary disorders• Reproductive system and breast disorders• Respiratory, thoracic and mediastinal disorders• Skin and subcutaneous tissue disorders• Social circumstances• Surgical and medical procedures• Vascular disorders
  57. 57.  Each MedDRA term assigned an 8-digitnumeric code The code is non-expressive Codes can fulfill a data field in variouselectronic submission types (e.g., E2b) Initially assigned alphabetically by termstarting with 10000001– New terms are assigned sequentially Supplemental terms are assigned codesMedDRA Codes
  58. 58.  Terms are being renamed– When terms are renamed, the code number isreused for the renamed term– Renaming has been done for spelling errors,hyphenation, and parenthesis changes When HLT or HLGT terms are removed fromthe terminology, they are deleted – NOTmoved to the LLT level and made non-currentMedDRA Codes (cont)Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  59. 59. Non-Current Terms Non-current terms are flagged at the LLTlevel within MedDRA Not recommended for continued use Retained within the terminology to preservehistorical data for retrieval and analysis Terms very vague, ambiguous, out-dated,truncated, or misspelled Terms derived from other terminologies thatdo not fit MedDRA rulesContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  60. 60. A Multi-Axial TerminologyMulti-axial = the representation of a medicalconcept in multiple SOCs Allows terms to be grouped by differentclassifications Allows retrieval and presentation viadifferent data sets Allows an automatic assignment ofpredefined term groupingsContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  61. 61. SOC = Respiratory, thoracic andmediastinal disordersHLGT = Respiratory tractinfectionsHLT =Viral upper respiratorytract infectionsHLT = Influenza viralinfectionsHLGT = Viral infectiousdisordersSOC = Infections andinfestationsPT = InfluenzaA Multi-Axial Terminology(cont)
  62. 62. PT = Diabetes mellitusHLT = Diabetes mellitus (incl subtypes)HLGT = Glucose metabolism disorders (incl diabetes mellitus)A Multi-Axial Terminology(cont)SOC = Metabolism andnutrition disordersSOC = Endocrinedisorders
  63. 63. What’s New for MedDRAVersion 15.1 MedDRA Version 15.1 was made availableto subscribers on 1 September 2012Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  64. 64. Clinical Trial End Product Ideal: Unambiguous conclusion regardingthe clinical outcome of the testtreatment/device. Always strive for the ideal, but in mostcases have to settle for the best comprise.Contact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  65. 65. Thank You ….Any Questions ?
  66. 66. Today’s AssignmentVisit www.sas.com to know more about SASContact : Balu India : +91-9966956770 +91-9966946199 USA: +1 (551) 226-6061www.sasonlinetrainings.com E-mail : contact@sasonlinetrainings.com
  67. 67. Please Visit……www.sasonlinetrainings.comAddress :SAS onlineTraining CenterNear Cyber Towers, Hitech CityHyderabad. Pin -500081Andhra Pradesh, India.E mail : contact@sasonlinetrainings.comIndia : +91-9966956770+91-9966946199USA: +1 (551) 226-6061Skype : appalanaidu412

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