Study termination data

The study termination form collects patient exit information from the clinical trial. Here is a sample study termination form  

The study termination form data may be used for efficacy or safety analysis purposes. With regard to safety, if patients discontinue a study medication earlier than patients on standard therapy or placebo, then that is important to know. For efficacy analyses, patients who withdraw due to a lack of efficacy or adverse event may be precluded from being considered a treatment responder or success. Also, often the study termination date is used as a censor date in time-to-event analyses for therapy efficacy. Study termination forms play a key role in patient disposition summaries found at the start of a clinical study report. From a CDISC perspective, the study termination form is a finding. 

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Demographics and Trial-Specific Baseline Data 27 Concomitant or Prior Medication Data 27 Medical History Data 29 Investigational Therapy Drug Log 30 Laboratory Data 31 Adverse Event Data 32 Endpoint/Event Assessment Data 35 Clinical Endpoint Committee (CEC) Data 36 Study Termination Data 37 Treatment Randomization Data 38 Quality-of-Life Data 40... 

In this example, it is known from non-database sources that at study termination, subject 101-1002 died. That information is hardcoded into the program and overrides the information coming from the clinical data management system. Here are two reasons why hardcoding is a bad practice ... 

The investigator must sign and date the final end-of-study (termination) page of the CRF verifying that the data entered are accurate and complete. This page is completed after the study procedures and visits per protocol requirements have been completed all applicable laboratory test results have been re-... 

As you can appreciate, with over 300 animals in a subchronic study being monitored periodically for any adverse health effect, one can accumulate literally thousands of continuous and terminal data points on biochemical, physiological, and morphological parameters which become a significant burden to the investigator and the staff. Management of this data is crucial. Most of the data flow control has become automated on computer. 

In all three studies, terminal hemograms and organ weight data were regarded as normal no drug - related tissue changes were observed. Subacute parenteral studies were conducted as the oral studies in both species. Excellent subcutaneous tolerance in the rat and intramuscular tolerance in the dog to 30 daily injections of 60 mg/kg of lincomycin was shown. 

Inclusion of an immediate release reference in the studies facilitates data analysis since it allows one to better estimate the terminal rate constant for... 

The regulatory procedure involved is a so-called Clinical Trial Authorization appH-cation (CTA) and consists, in addition to a Clinical Trial Protocol (CTP) and Investigator s Brochure (IB), of an Investigational Medicinal Product Dossier (IMPD) in CTD format. The IMPD consists of quality data, nonclinical pharmacology and toxicology data, clinical trial and previous human experience data, and an overall risk-benefit assessment. A copy of the CTA is sent to each EU Member State where the study is conducted, as well as to the Ethics Committees for approval. These also have to be notified in case of any amendments, study termination and adverse reactions. The contents of the IMPD are case specific and may be simplified or even replaced by the... 

Samples of each batch should be retained in the primary container used for the study or in a suitable bulk container for at least 2 years after the termination or completion of the relevant clinical trial. If the sample is not stored in the pack used for the study, stability data should be available to justify the shelf-life in the pack used. 

It is tempting to attribute problems in reconciling data from model studies and actual polymerizations to difficulties associated with data interpretation. The polymerization experiments are often complicated by other termination pathways, in particular chain transfer, which must be allowed for when assessing the results. It is notable in this context that the discrepancies are most evident for reactions carried out at higher temperatures (Sections 5.2,2.1.1 and 5.2.2.1.2). 

Perhaps because of this complexity, few studies on determining kld/ktt, in cross termination in copolymerization have been reported and most of the available data come from model studies, it is also usually assumed, without specific justification, that penultimate unit effects are unimportant in determining which reactions occur and that values of k klt for the homotermination reactions are similar to those in the corresponding homopolymerizations. 

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