Talk:Investigator's brochure

message: This article is part of a series of articles trying to provide additional information on several aspects of clinical development (trying to fill some gaps)
Hello, fellow AMWA classmates, I've completed my minor edits to the page. I find it very confusing to follow the Wikipedia style guide. Perhaps someone can correct the way I've edited the references and the external links. Terimedwriter (talk) 23:17, 28 July 2009 (UTC)
thread_title: Comments

message: Question for the Instructor: I have worked on 2 IBs recently and both times have found it difficult to reduce the size of the final documents. New information is added to the IB, but nothing is deleted. Do you have any suggestions on avoiding this scenario? Terimedwriter (talk) 17:30, 29 July 2009 (UTC)
thread_title:  Keeping the Investigator's Brochure a Summary of Information, not a Compilation 

message: Why is the chemical/structural formula necessary for the clinician and could providing such detail cause an intellectual property risk? Rodnator (talk) 19:05, 28 August 2009 (UTC)
replies: text: That's an interesting point.  Intellectual property is usually safeguarded by confidentiality agreements for that very reason.  I wonder, though, if the stringency of these agreements tends to change throughout development phases?  Seems logical that they would, as the competitive concerns for a first in humans Phase I trial are quite different from, say, a Phase IV trial, but I'm no J.D.... thoughts, anyone? [-JER} Jeruckle (talk) 11:20, 3 October 2009 (UTC)

text: In my experience (I admit I'm relatively new to the field), the PI scrutinizes the IB... but most of my work is early in development and with PIs who take a very hands-on approach to their studies.  I would suspect that Investigator use of the IB varies widely, depending on how well the drug has been studied, whether or not the Investigator has worked with the compound before, in what population is the drug being studied, whether the Investigator is more of a clinician or more of a researcher, etc.  I wonder what others have seen in their experience...? [-JER] Jeruckle (talk) 11:20, 3 October 2009 (UTC)
thread_title:  Investigational product properties 

message: Question for the instructor: Is an IB required for a clinical trial that is not regulated by FDA? For example, an investigator at NIH may start a clinical trial to evaluate a marketed drug to determine whether there is any association of the drug use with an increase in certain diseases (side effects).
Hankipo123 (talk) 20:01, 18 September 2009 (UTC)
thread_title:  IB requirements for regulated clinical trials vs. non-regulated trials 

message: Question for the instructor: 
I added my name to my edits so that you could see they are there. However, it certainly makes the text hard to follow when it's cluttered up with contributors' names. If I remove the tags, would you still be able to tell that I've done my homework?
I also have a question about updates, similar to the question above. If a clinical program is very active, many new studies may need to be incorporated and described. In a new edition, to what extent can the old version of the IB or an approved label be referred to without having to repeat everything that was there before ?
Thanks for this assignment! This is a very interesting exercise, even apart from the stated goal of learning about IBs. Whenever I refer to the guidances, I am always amazed at how general and sketchy they are. From these vague instructions massive piles of requirements arise for the pharma company regulatory documnets I work on.CAS57 (talk) 22:24, 18 September 2009 (UTC)
thread_title:  Hello Classmates and Question  

message: Hello,
I have noticed that this appears to be a school project. Might I suggest looking at and signing up at Wikipedia:School and university projects? This page includes some tips and tricks to get new editors started, as well as advice for the instructor to ensure that what they are doing falls within Wikipedia guidelines. 
For example, it is inappropriate to sign your username in an article (but important to do it on the talk page!). Should the instructor wish to review who has contributed what, all the edits can be found under the "history" tab at the top of the page.
Happy editing,
shoy (reactions) 01:05, 23 September 2009 (UTC)
replies: text: Thanks, this is very helpful! TheFifthSmith (talk) 05:06, 30 September 2009 (UTC)
thread_title:  School project 

message: Hi all, I added my edits with 3 objectives carefully in mind, because you all did such a good job ahead of me I didn't want to be contributing verbiage without substance. So, I emphasized (1) the role of the IB in maintaining the safety of human subjects in clinical trials; (2) added other guidances IB authors often refer to; and (3) added IB content details taken from the guidances noted as well as from other, more specific guidelines, such as the guideline for deriving a safe dosage in humans.
Best, NMSISI (talk) 11:26, 23 September 2009 (UTC)
thread_title:  NMSISI edits 

message: What has been your experience with the inclusion of a specific "expected" AE table? This is based on recommendations of the CIOMS VI working group that Development Core Safety Information (DCSI) should be added to the IB and use as the definitive list of expected events for regulatory reporting purposes. I have seen this done by 2 clients so far. I have also seen confusion in this regard!Martha1279 (talk) 20:59, 27 September 2009 (UTC)
thread_title: Question regarding AE Tables

message: Question for AMWA Instructor: The current article has numerous subheadings toward the end of the article that seem to go beyond ICH guidance and its suggested outline. Furthermore, those subheadings have no content. Did you put them there and expect your students to develop the content? I ask before I start editing because I'd be inclined to remove them. Thanks for your reply. D Pantelis (talk) 21:02, 28 September 2009 (UTC)
replies: text: I have the same question. I looked at the history tab and could not figure out who added those headings or when. Only a dozen people have been here recently so perhaps it is to make sure everyone gets to write something. I am adding a bit to several topics based on my knowledge, but as you point out, much of it is does not seem to be covered in the prereading.  TheFifthSmith (talk) 05:13, 30 September 2009 (UTC)
replies: text: I recognized this too - I went ahead and filled in a few of these sections as adapted from content from sample IB documents and in cases where some of the information overlaps with the IND.  I also share another author's concern regarding inserting references, more specifically citing a reference that has already been cited (equivalent to inserting a cross reference).  I was not able to do this efficiently, certainly several of the references may overlap and this functionality would be useful.  I look forward to learning from all of you.  Write Bright (talk) 19:18, 30 September 2009 (UTC)
thread_title:  Subheadings of Undeveloped Content 

message: Question for AMWA Instructor: Why would the IB need to be updated after a market approval and the drug becomes commercially available?  Is this assuming there's another trial going on somewhere? Thanks! Chilirabbit (talk) 06:15, 2 October 2009 (UTC)
thread_title:  IB Update 

message: Hi Jane,
Can the IB be submitted electronically or is it by hardcopy submission only?
cheers,
oki...  —Preceding unsigned comment added by Okd007 (talk • contribs) 20:14, 2 October 2009 (UTC)
thread_title:  Question for Jane 

message: What is the general trend for frequency of updates to the IB across development phases (more frequent updates early or late in development)? Jeruckle (talk) 10:49, 3 October 2009 (UTC)
thread_title: Question for Jane

message: I am finding that editing the IB through wikipedia is not very user friendly! I am spending more time trying to get things to work than editing. And in editing it is very hard to read; the window is too small. Wpharm2 (talk) 22:16, 2 October 2009 (UTC)
thread_title:  Hard to edit 

message: I am having difficulty with understanding use of references for nonclinical studies of products in early development. Little information may be published as the know body of information is summarized in Technical Reports that are not readily available to Investigators or IRB's.  In the absence of information published in public domain, is it of common practice to just provide the technical report number?  Mk3521 (talk) 18:53, 11 October 2009 (UTC)
thread_title:  Use of non published references in IB 

message: --The  copyeditor's corner 19:50, 25 May 2011 (UTC)
thread_title: GoCE