Definitely. This category applies to those AEs that the investigator feels are incontrovertibly related to test product. An AE may be assigned an attribution of definitely related if or when it meets all of the following criteria: (1) it follows a reasonable temporal sequence from administration of the product; (2) it could not be reasonably explained by the known characteristics of the subject’s clinical state, environmental or toxic factors, or other modes of therapy administered to the subject; (3) it disappears or decreases on cessation or reduction in dose and recurs with re-exposure to product (if rechallenge occurs); and (4) it follows a known pattern of response to the test product. When changes in the intensity of an AE occur more frequently than once a day, the maximum intensity for the experience should be noted. If the intensity category changes over a number of days, then those changes should be recorded separately (with distinct onset dates).
Definitely. It allowed us to evaluate current programs and to think about how we would "market" to specific populations 32. yes, good discussion ideas and brainstorming
Definitely. Yes, sir.
Definitely. Thus, while plaintiff indicated that sale of the house was a possibility, he indicated to Xx. Xxxxx that he did not want to choose that option. Furthermore, when asked whether he told Xx. Xxxxx that he might not be able to keep the house, plaintiff’s answer was evasive. He stated: Because of everything that was going on in and around that time, Xxxx [XxXxx, the questioning attorney], between working with the business and trying to get that back on its feet and working with the creditors, the accountants in reference to the dischargeability just prior to that, and all the other things that were going on financially, the divorce and so forth, I was just really pretty much upside-down. In addition, plaintiff’s testimony indicated that he, himself, did not see sale of the house as a realistic option. Plaintiff testified that “[w]ith the bankruptcy I was advised that the odds that I could get a mortgage if I could sell the house were nil, slim to none. And so my intentions were to keep the house. And I liked the house.” Plaintiff’s communicated intention to keep the Clubhouse Drive property impacted the method by which Xx. Xxxxx valued plaintiff’s house. Instead of waiting for an actual sale of the home to occur to get an actual market value, Xx. Xxxxx estimated the valuation of the house at $300,000.00 based on comparable properties information which plaintiff supplied. This was not Xx. Xxxxx’x preferred method of establishing a value for the house, a value which largely determined plaintiff’s total equity in his real and personal property that was available to satisfy the IRS lien. Xx. Xxxxx explained at trial:
Definitely through times education has changed, so much, so that it has taken a big step in this area, going back 20 years ago where the teaching of English was almost non-existent, mainly due to lack of resources for advanced technology. I remember in those years where I had the opportunity to become teachers, to more than the apathy and disinterest of the students had the worst of enemies, lack of educational resources, the few hours devoted to teaching the English language. At that time made use of charts and pictures and books obsolete in order to teach. Very different in modern times, as I said before households have a computer, the young people listen to music in English, they are attracted by Americana culture and it is language and point as a target to reach an English speaking country either USA or England. They have seen the need to go further in their educational purposes in a very competitive world today.
Definitely. Strong evidence exists that the study procedure or device caused the AE. There is a temporal relationship between the event onset and the study procedure or device. There is strong mechanistic evidence that the event was caused by the study procedure or device. The subject’s clinical state and concomitant therapies have been ruled out as a cause. 15 CLINICAL STUDY ADMINISTRATION AND INVESTIGATORS
