Serious adverse event procedures

PROCEDURES FOR MONITORING AND RECORDING ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS... 

Assessment of safety Specification of safety parameters Methodology of assessing safety parameters Handling of serious adverse events Handling of ordinary adverse events Procedure for breaking codes... 

It is very important to assess the qualifications and availability of the subinvestigators conducting the study with the principal investigator, who is a field expert, as the subinvestigators will be responsible for performing the majority of study procedures and reporting serious adverse events. 

MedWatch. URL http //www.fda.gov/medwatch/index.html. The FDA s MedWatch Web site outlines procedures for voluntary reporting of serious adverse events or product problems by consumers and healthcare practitioners. It also includes... 

Conceptually, the potential complications of CRT-pacemaker or CRT-defibrillator implantation include the known complications of transvenous pacemaker or ICD implant (bleeding, infection, pneumothorax, vascular injury, cardiac perforation/tamponade, and cardiac decompensation from defibrillation testing) as well as the potential complications of LV lead implant (coronary venous dissection/perforation, contrast nephropathy, and perhaps elevated risk of infection or heart failure exacerbation due to prolonged procedure times). In addition, the passive fixation nature of LV leads raises the rates of post-procedure lead dislodgement. However, the rates of serious adverse events from the implantation procedure reported in the large clinical trials have been low. In MIRACLE, 2 patients (of 571) died as a result of the procedure. Correspondingly, 6% had a dissection or perforation of a coronary vein, but only 3 of those 35 patients required intervention and... 

To be a successful monitor, the sponsor representative should know how to interpret hospital/ clinic records/charts, laboratory tests, and interpretations has to query resolution procedures protocol and CRF data requirements medical nomenclature Serious adverse event (SAE) procedures and health authority requirements. In addition, a monitor needs to have excellent interpersonal communication and problem-solving skills. 

To comply with the new legislation the sponsor needs to develop a set of standard operation procedures (SOPs) to cover all areas of trial activities. A quality system should be in place to ensure record-keeping and verification of data entry or extraction of data from the case report form (CRF), capture adverse events (AEs), serious adverse events (SAEs) and unexpected serious adverse reactions (SUSARs) and report in an expedited manner data transfer from source data to database and archiving of the source data for audit purpose. GCP and trial specific training should be carried out and recorded in a timely manner. 

Wahl PM, Rodgers K, Schneeweiss S, Gage BF, Butler J et al. 2010. Validation of claims-based diagnostic and procedure codes for cardiovascular and gastrointestinal serious adverse events in a commercially-insured population. Pharmacoepidemiol. Drug Saf. 19 596-603. 

Respiratory An audit of a case register of a large pediatric emergency department has shown that of 2002 patients receiving pediatric procedural sedation (60% male, median age 6 years), 81% received nitrous oxide and 1% received nitrous oxide + midazolam [18 ]. There were serious adverse events in... 

Systematic reviews A systematic review of the reported adverse events of chiropractic procedures has shown that most of the adverse events reported were benign and transient however, there were reports of complications that were serious or life threatening, such as arterial dissection, myelopathy, vertebral disc extrusion, and epidural hematoma [130 ]. The frequency of adverse events was 33-61%, while the frequencies of serious adverse events were 5 strokes/ 100 000 manipulations, 1.46 serious adverse events per 10 000 000 manipulations, and 2.68 deaths per 10 000 000 manipulations. 

The Directive contains detailed articles on the conduct of a clinical trial, exchange of information between Member States, EMEA, and the EC, the reasons and procedures for suspension of the trial by a Member State, and notification of adverse events, including serious adverse reactions. 

The Commission, in consultation with the Agency, Member States and interested parties, shall draw up and publish detailed guidance on the collection, verification and presentation of adverse event/reaction reports, together with decoding procedures for unexpected serious adverse reactions. 

Blood products, which include whole human blood for use in transfusion as well as blood-derived products such as clotting factors, proteins, etc. The term baemovigilance is used to describe the surveillance procedures adopted to monitor serious adverse or unexpected events related to products derived from blood. 

The results of this Phase IIA multiple intravitreal injection clinical study of anti-YEGF therapy expanded the favorable safety profile reported in the Phase IA single-injection study. Specifically, the Phase IIA study showed that three consecutive anti-pegaptanib sodium intravitreal injections given monthly did not cause serious ocular or systemic adverse events. The adverse events encountered appeared to be unrelated to study drug and were generally minor. In most cases they were probably related to the intravitreal injection procedure or to the PDT therapy. These results provided the basis for the Phase III pegaptanib sodium trial described below. 

The ]1970] act did not specify any abatement procedure in the event that a stationary source in one State did emit air pollutants which adversely affected the air quality control efforts of another State. As a result, no interstate enforcement actions have taken place, resulting in serious inequities among several States, where one State may have more stringent implementation plan requirements than another State. For example, an implementation plan for the State of Ohio was not even proposed until 1976. It has now been challenged in court and has not yet been effectively implemented. As a result, there are no enforceable control requirements applicable to most of the significant major... 

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