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1. In your protocol dated 3/31/00, you added a site selection and randomization schedule under the heading "Design", which was designed to compare two sites of similar area and depth for each test. This design addition is not in the sponsor's original protocol nor did you receive approval for this change.
A. The Institutional Review Board (IRB) approved the informed consent form (ICF) on September 6, 2000. The first (redacted) subjects enrolled between April 15, 1998 and July 17, 2000, and signed informed consents that were not approved by the IIRB Dr. Boyce's response indicates that only approved ICFs will be available to the clinical investigators. Unsigned, expired consent forms are to be destroyed with the exception of the file copy. Also, he indicates that prior, blank versions will be removed when a new ICF has been approved. However, FDA requests information regarding who will be responsible for this procedure and who they will report to.
1) On [redacted] subject [redacted] had positive cultures for [redacted] of her which resulted in clinical sepsis. She was treated with triple antibiotic therapy of [redacted] and [redacted]. This event was not recorded on the adverse event case report forms (CRF) and there was no documentation of reporting this event to the sponsor, IRB, and FDA.
2) Subject [redacted] developed an infection of the left posterior [redacted] positive with [redacted] and Staph species on [redacted] Infection of the [redacted] is not identified in the protocol as an anticipated event therefore, it was an unanticipated adverse device effect and required reporting to the reviewing IRB and sponsor. There is no documentation of this event being reported to the sponsor, IRB, and FDA.
3) Subject [redacted] Qualitative Outcome Assessment CRF noted [redacted] of [redacted] for both [redacted] and [redacted] however there is no documentation of reporting of this event to the sponsor, IRB, and FDA.
4) Subject [redacted] Qualitative Outcome Assessment CRF's dated [redacted], and [redacted] identified [redacted] as [redacted] This is an unanticipated adverse device effect; however, there is no documentation of reporting of these events to the sponsor, IRB, and FDA.
The investigational devices, [redacted] did not contain the proper labeling.
Applying these per stay estimates to the total number of S. aureus stays in the United States in a given year results in an estimated 2.7 million days in excess length of stay, $9.5 billion in excess charges, and close to 12,000 inpatient deaths per year. The differences remained significant when also comparing hospitalizations with S. aureus infections with other types of infections.
Why do the Shriner hospitals have competitors?
I'm angry to hear what these people are doing with the donations.
I'm furious to hear about children being abused.
Forgive me.
Originally posted by relocator
reply to post by getreadyalready
I have no agenda other than posting my opinion. You don't have to agree or read it or even like it. I'm okay with that. But I will state it whether I'm right or not. Nobody is right all the time.
I'm angry to hear what these people are doing with the donations.
I'm furious to hear about children being abused.
Forgive me.
Originally posted by relocator
Good deeds don't excuse the crimes being commited or taxes not being paid and partying like a rock star.
Shameful...
Originally posted by relocator
reply to post by emsed1
I guess you didn't read the article that the OP posted. It would greatly help and keep me from having to read it to you.
I'm done with this thread. Good bye
Question: Do you know if they came with a certain organization?
Answer: The manager said that they were Masons. I didn’t know what Masons were. To me, it was like a religion, like a belief.
Question: Was it your understanding that there were certain Masons that came on these tours?
Answer: Right.
Question: Do you know what a Mason is?
Answer: I didn’t know what it was, but now I know that it’s an organization of people that are all over the world.
Question: Do you know if all these individuals in this picture were identified to you as being Masons?
Answer: Yes, it was a group.
Question: Were the two people in the prior picture a part of the Mason group?
Answer: It was the same group. For sure it was the same group.
This request from Assistant US Attorney Marlene Rodriguez asks Amelia to talk with agents because “according to information that ICE and FBI supplied, Ms. Schair was involved with a company and/or an individual who may have engaged in child sex tourism in Brazil.”
I'll give my OPINION on all of Freemasonry and Jesters in particular. This is not to encourage anything by anybody but I believe they should be hunted down and killed where they stand. Their temples should be burned to the ground. Every one of them. People like Penn State's Jerry Sandusky, who is now on trial for his Jester crimes, should not even get a trial. He should be tortured to death immediately without further ado. Now some might say this is wrong of me to think this way. But if YOU has been sexually abused as a child you would understand my shear and utter hatred of these demented satanic dogs from Hell. Freemasonry and those who practice it need to be exterminated from this planet with extreme prejudice by any means expedient.
Newsvine, the company, is not a news bureau and exercises no editorial voice, but acts as a social news platform for the community which has grown around it. Members decide with their actions what news makes it onto the site and what news is removed.
Originally posted by relocator
Shriners Hospitals for Children...Ever heard of them? Well Guess who is opening a new one: