Study completion date

Experimental starting date Experimental completion date Studyinitjalion date Study completion date... 

The FDA has indicated that study initiation date (defined in 58.3(e)) and study completion date (defined in 58.3(p)) are administrative dates and should not be used to determine whether or not a study is of more than 4 weeks duration. Instead, terms-of-the-art (e.g., 14-day acute study, 28-day repeated dose study, etc.) will determine whether reserve samples are required under 58.105(d). 

The study initiation date, which is the date that is entered on the master schedule, is defined as the date the protocol is signed by the study director. The study completion date will refer to the date that the final report is signed fcy the study director. 

Study completion date" means the date the fined report is signed ey the study director. 

Study start date Study complete date Final report ... 

Four time points have been defined in the OECD Principles for start and end of a study. The so-called study initiation and study completion dates do not contain any ambiguities that could give rise to interpretation difficulties. The dates when the Study Director signs study plan and final report are unambiguous calendar dates, and they clearly mark the two time points between which a study has been conducted. However, more difficulties are encountered with the experimental starting and completion dates for themselves and for their connection with initiation and termination dates. 

This may certainly prove to be difficult at times, especially in the context of a study of relatively short duration. In such a case, one can imagine that the Study Director would possibly have had to decide on the spot about some necessary (but nevertheless planned) change. To dictate the amendment and to have it typed by the secretary, or to go back to the office and to type it himself, to date and sign it, and to distribute the necessary copies to all the persons concerned, including the Quality Assurance, would in such a case take too much time. Unless the change could be immediately implemented (and the amendment written later), the study would in all probability have to be aborted. Thus, a certain latitude in the interpretation of the resemblance of an amendment with the study plan can certainly be exercised. When, however, in longer term toxicity or field studies amendments are uncovered that are concerned with some start parameters of the study, but which are written (or at least dated and signed) well after the experimental start date, or maybe even after the experimental study completion date, then the correct term for such a document is certainly not Amendment anymore, because in this instance it has failed the intentions of the GLP Principles, namely that the amendment... 

Study completion date means the date the Study Director signs the final report. 

Final Report signed (Study Completion Date)... 

The study completion date is the point when the last sample was pulled, tested, and all results are reported. This time marks the end of the study. A study is not considered complete if there is an open investigation on any result. 

The protocol will provide important date and time requirements. Estimated start and completion dates for the study are required by regulation. In addition, the Study Director may specify a maximum storage time of the RAC prior to processing if the chemical in question or its metabolites degrade rapidly. A maximum time after generation of a processed fraction before that fraction is placed into frozen storage may also be specified. A maximum storage time prior to shipment may also be specified. 

The cracking method is possible, as the amorphous carbon does give high nonoampere ion currents. However, the problem of isotopic fractionation, when cracking of the gas is incomplete, has yet to be studied completely. The method is somewhat wasteful, as not all of the gas sample is cracked, and so the full potential of the accelerator-dating method is not realized. 

Most FPA studies to date on DNA have lacked sufficient time resolution to observe directly the relaxation of the internal correlation functions. Instead, the initial anisotropy r0 is taken as an adjustable parameter. Equations (4.30) show that such a procedure is completely valid for anisotropic diffusors (i.e., (A ft)2 = (dx(t)2)), provided the rapid internal motion of the transition dipole is isotropic. It has not yet been ascertained whether the internal motion actually is isotropic, so this must be assumed.(83) A recent claim(86) that large amplitudes of polar wobble are required to fit both the small amplitude of initial FPA relaxation 87 and the linear dichroism88 has been refuted. 83j... 

The FDA has required a conforming amendments statement for all nonclinical laboratory studies submitted to FDA after June 20,1979, the effective date of the GLP regulations. A conforming amendments statement was thus required for studies completed prior to June 20, 1979, if the results of the studies were submitted to FDA after that date. 

The kinetics of the acid hydrolysis of dihydroxo-bridged cobalt(III) complexes have been studied for both cationic and anionic species. The stoichiometry of the hydrolysis reaction for cationic complexes can be expressed by Eq. (56). The equilibrium lies completely to the right at low pH (typically less than 3) and the reverse process in Eq. (56) can normally be disregarded. For all the systems studied to date the observed rate laws can be interpreted in terms of Scheme 4. 

In the only study to date of the mechanism of PFS initiation, Sims (40) could conclude only that polymerization of THF with PF5 as catalyst is a very complex system. He found that there appears to be a slow initiation reaction which does not reach completion until at least half of the polymerization is over. Sims also studied the effect of water on the polymerization, but could not fully explain the complex results. He... 

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