Expedited Reports

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... 

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

In addition to the expedited reporting described above, sponsors shall submit, once a year throughout the clinical trial, or on request, a safety report to the Competent Authority and the Ethics Committee. This should cover SUSARs, other serious adverse reactions, and an analysis of the subjects safety during the course of the trial. 

Effects not mentioned in the Summary of Product Characteristics or of a more severe nature Expedited Reporting... 

The criteria used to identify events that require expedited reporting to European regulatory authorities are shown in Figure 12.6. The maximum time allowed for the submission of an expedited report is 15 days. The clock starts from the time that any... 

Table 12.2 Forms to be use for expedited reporting of adverse events.

The forms used for expedited reporting of adverse events are listed in Table 12.2. An example of mandatory reporting form FDA3500A is shotvn in Figure 12.9. 

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 ... 

A facile method for the oxidation of alcohols to carbonyl compounds has been reported by Varma et al. using montmorillonite K 10 clay-supported iron(III) nitrate (clayfen) under solvent-free conditions [100], This MW-expedited reaction presumably proceeds via the intermediacy of nitrosonium ions. Interestingly, no carboxylic acids are formed in the oxidation of primary alcohols. The simple solvent-free experimental procedure involves mixing of neat substrates with clayfen and a brief exposure of the reaction mixture to irradiation in a MW oven for 15-60 s. This rapid, ma-nipulatively simple, inexpensive and selective procedure avoids the use of excess solvents and toxic oxidants (Scheme 6.30) [100]. Solid state use of clayfen has afforded higher yields and the amounts used are half of that used by Laszlo et al. [17,19]. 

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

Reporting Forms. FDA form 3500/3500A (see Figure 20.1) is the standard form for notifying expedited reports and can also be used by companies to submit IND safety reports. Foreign cases may be reported on the CIOMS I form. 

Quality control, however, needs more attention. For example, it has been reported that much of the chemical data produced by the International Indian Ocean Expedition is unusable because of doubts about its accuracy. Such reports are a perennial source of confusion in marine chemistry. Better calibration, universal standards, and interlaboratory comparison are essential if we are to continue our present field methods, in which independent investigators make measurements that are presumably comparable (NRC, 1971, pp. 54-55). 

The generally expected reporting requirements for serious adverse reactions (expedited reporting) are as follows ... 

All such reports should be reported immediately and in no case later than 15 calendar days from receipt. The clock for expedited reporting starts as soon as one or more of the following has received the minimum information reqmred for the submisssion of an adverse reaction report ... 

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)]. 

CN004 Haddon, A. C. Reports of the Cambridge anthropological expedition to Torres straits. Cambridge University Press, England 1908 6 107. 

It is anticipated that CDER will shorten the review time for biotechnology products, and make the review process for biologies and traditional chemical drugs more parallel. Media reports say that the biotechnology industry welcomes this move with the hope that it will expedite new drug approvals. 

---