Calendar days

An auditor auditing the day and evening shift may accumulate more than 8 hours in one day, therefore man-days are not calendar days but divisions of 8 audit hours. 

Disoriented for date by no more than 2 calendar days... 

Time Frames. The time period for submitting written IND safety reports has been revised from ten working days to 15 calendar days. For telephone reports (fatal and life-threatening unexpected reactions), it has been revised from three working days to seven calendar days. Such reports can also be made by fax. Telephone reporting was previously restricted to clinical studies conducted under the IND, but under the new rule, telephone reporting within seven calendar days applies to any unexpected fatal or life-threatening reaction from any source. 

The time period for submitting NDA alert reports (serious and unexpected) has been revised from 15 working days to 15 calendar days. 

A periodic report contains certain information, such as the event terms submitted during the period, the dates that events of the period were submitted, an event term count by body system, and labeling changes made due to the period s adverse experiences. In addition to (and prior to) being incorporated into a periodic report, 15-day reports are submitted within 15 calendar days of the date the applicant received the data. All 15-day reports contain serious, unexpected events. Non-15-day reports are submitted periodically in FDA periodic reports. 

A report of any unexpected serious adverse reactions or information regarding similar reports received from the sponsor as soon as possible and, in no event later than 15 calendar days after the invest gator discovers the information... 

Initial inspection of Figure 10.1 showed what appears to be a cyclical pattern in the clearings and issues. This was confirmed by the statistical process control charts in Figures 10.2-10.4. The broad peaks and valleys in Figure 10.1 seem to repeat every 20 to 25 days. At first, this seemed to be a strange number of days for a cycle - a monthly cycle of 30 or 31 days would have made more sense to some of us. However, the student was quick to point out that the average business month has between 21 and 22 days (365.25 calendar days per year) x (5 business days per week) / (7 calendar days per week) = 260.89 business days per year which, when divided by 12 months, is 21.75 or approximately 22 business days per month. 

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 ... 

A Clinical Trial Exemption (CTX) Scheme was introduced in Australia in 1987, with the intention of encouraging clinical trial activity. However, in addition to the aforementioned TGA restrictions, which required all clinical trials of an active substance underway in Australia to be completed before the review of a general marketing application relating to that substance, the specified data package included requirements unique to Australia, and the 60 working day review period compared with a 35 calendar day review imder the UK CTX Scheme. 

The decision of the secretary or delegate is called an initial decision. If the sponsor wishes to appeal an initial decision, it must do so within 90 calendar days of receiving advice of that decision. The appeal of the initial decision is directed to the minister, who generally appoints the TGA principal medical adviser to act as a delegate in considering that appeal, and the decision on the appeal must be issued within 60 days. The outcome of this stage is called a review-able decision. Reviewable decisions are so-called... 

Despite the TGA s adoption of these international requirements, the local interpretation of these guidelines in relation to reporting serious and unexpected adverse reactions must be adhered to. Sponsors of clinical trials are required to report to TGA single cases of serious and unexpected adverse reactions. Fatal or life-threatening ADRs should be reported within seven calendar days of the reaction first being notified to the sponsor. This should be followed by as complete a report as possible within eight additional calendar days. All other serious and unexpected ADRs should be reported to TGA within 15 calendar days of first knowledge of the sponsor. 

Pharmaceutical companies are now required to report all serious suspected ADRs to the CSM within 15 calendar days of receipt of the original information by the representative or other appropriate employee. Companies are also now obliged to submit reports received from all health professionals... 

Note It is as well to inform doctors who report ADRs to medical representatives that the company is legally obliged to report the ADR to the CSM in 15 calendar days, and that a rapid reply would be appreciated if further information is required. 

The other commercialized pentane isomerization process is that of the Standard Oil Co. (Indiana) (20). This process differs from the Indiana-Texas butane process in that the aluminum chloride is introduced as a slurry directly to the reactor and that about 0.5% by volume of benzene is added continuously in the feed to suppress side reactions. Temperature, catalyst composition, space velocity, and hydrogen chloride concentration are generally similar to those in the corresponding butane process, but the reactor pressure is about 100 pounds lower. The Pan American Refining Co. operated the Indiana pentane isomerization process commercially during the last nine months of the war and produced about 400 barrels of isopentane per calendar day. 

After Morley s retirement, Miller continued a lonely quest for more than 20 years. He repeated the experiment many times at Cleveland and at Mount Wilson, and typically found a nonnull difference of speed around 10 km/s [53-55]. More importantly, he carried out measurements during a whole calendar day, spaced at intervals of three months. He identified seasonal variations both in the magnitude of the difference of speeds, and in the shape of the daily curve [53]. He ascribed the seasonal variations to a motion of the solar system of 208 km/s relative to the fixed stars. This velocity is of the same order of magnitude as the currently accepted ys- 10 V However, his argumentation was not clear enough at that time. 

REFINING SRC-II OIL BY HIGH SEVERITY HYDROTREATING TO PRODUCE 50,000 BARRELS PER CALENDAR DAY OF MOTOR GASOLINE PLUS JET FUEL DOE CONTRACT EF-76-C-01-2315 ... 

Feeds and Products, Barrels per Calendar Day Refinery Input High Severity Hydrotreating Catalytic Reforming Hydrogen Manufacture Recovery and Sulfur Plant Refinery Fuel Motor Gasoline Kerosene Jet Fuel By- Products... 

Hydrogen, Millions of Standard Cubic Feet Per Calendar Day (174.9) 17.0 157.9 ... 

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