Safety Data Management

One key feature in CAPE-SAFE is the management of all safety-related data via the interfaces with other components within PEEE. Safety data groups can be viewed as in table 8-1. 

Data Group Data Elements Management Meehanism 

Hazard Evaluation Hazard, Plant, Process, Equipment, Process Variables, Position, Cause, Consequence, Initial-Event (Root Cause) Develop/generate by safety experts/engineers/auditors Follow-up and monitor by CAPE-SAFE and safety experts/engineers/auditors 

Safety Procedures Kejnvord, Condition, Rule, Action, Owner, Participants, Validation, Plant, Process, Equipment, Position, Operation Download from PSP Generate and maintain by CAPE-SAFE Assess by safety experts/engineers/auditors 

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E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions E2A Clinical Safety Data Management Definitions and Standards for Expedited Reporting... 

E2B(R3) Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports... 

E2C(R1) Clinical Safety Data Management Periodic Safety Update Reports for Marketed Drugs... 

E2D Post-Approval Safety Data Management Definitions and Standards for Expedited Reporting... 

Just as there is an adverse event form, there is usually a serious adverse event (SAE) form. Note here that serious as defined by the FDA is different from severe on the adverse event form. A patient can have a severe headache that may not be considered serious. The ICH guideline (also in ICH E3) entitled Clinical Safety Data Management Definitions and Standards for Expedited Reporting defines serious adverse events as follows ... 

The extent of population exposure to assess clinical safety Clinical safety data management Definitions and standards for expedited reporting... 

International Conference on Harmonisation (ICH) of Technical Requirements of Pharmaceuticals for Human Use. Topic 2 A Note for Guidance on Clinical Safety Data Management Definitions and Standards for Expedited Teporting, CPMPIICHI377I95. London European Agency for the Evaluation of Medicinal Products, 1994. 

ICH E2B(M) Clinical Safety Data Management data elements for transmission of individual case safety reports. 

ICH Topic E2C Clinical Safety Data Management periodic safety update reports for marketed drugs. 

Specification (M2)], ICH/287/95 [Guidance on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports (E2B)], ICH/288/95 [Guidance on Clinical Safety Data Management Periodic Safety Update Reports for Marketed Drugs (E2C)], and ICH/377/95 [Clinical Safety Data Management Definitions and Standards for Expedited Reporting (E2A)]. 

Guidelines on validation of analytical methods implemented. Guidelines on impurities in new drug substances implemented. Guidelines on clinical safety data management enforced. 

The type of ADR to report and the time limits are defined by the international guidelines on Safety Data Management. In addition, periodic safety update reports are sent to the MHLW with respect to these international standards. Traditionally, in Japan, ADRs are classified into three grades (mild, moderate, severe), according to severity criteria, and into function of the body apparatus. 

ICH E2 (1994) described clinical safety data management. The now familiar definitions and standards for expedited reporting of individual adverse events when serious, unexpected and treatment associated are the result of ICH E2 (and the regulatory transcriptions, e.g. 21CFR312.32). 

E = Efficacy Topics those relating to clinical studies in human subjects. Examples E4 Dose Response Studies. Carcinogenicity Testing, E6 Good Clinical Practices. (Note Clinical Safety Data Management is also classified as an Efficacy topic, E2). 

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