Produced by Araxis Merge on 7/17/2018 6:16:26 PM Eastern Daylight Time. See www.araxis.com for information about Merge. This report uses XHTML and CSS2, and is best viewed with a modern standards-compliant browser. For optimum results when printing this report, use landscape orientation and enable printing of background images and colours in your browser.
# | Location | File | Last Modified |
---|---|---|---|
1 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp | Investigational Drug online content.docx | Fri May 18 20:15:06 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\OnlineHelp | Investigational Drug online content.docx | Tue Jul 17 21:17:43 2018 UTC |
Description | Between Files 1 and 2 |
|
---|---|---|
Text Blocks | Lines | |
Unchanged | 2 | 22 |
Changed | 1 | 2 |
Inserted | 0 | 0 |
Removed | 0 | 0 |
Whitespace | |
---|---|
Character case | Differences in character case are significant |
Line endings | Differences in line endings (CR and LF characters) are ignored |
CR/LF characters | Not shown in the comparison detail |
No regular expressions were active.
1 | Investigat ional Drug Online Co ntent | |
2 | Investigat ional Drug : An inves tigational drug is a chemical or biologi cal drug t hat is use d in a cli nical inve stigation. | |
3 | (1) An inv estigation al drug ca n be: | |
4 | (a) A new chemical c ompound, w hich has n ot been ap proved by the FDA, o r | |
5 | (b) An app roved drug that is b eing studi ed for an approved o r unapprov ed use, do se, dosage form, adm inistratio n schedule , or under an IND ap plication, in a clin ical inves tigation. This inclu des: presc ription dr ugs, over- the-counte r drugs, n utritional supplemen ts, herbal preparati ons, and l egend item s used for the diagn osis, trea tment, cur e, mitigat ion or pre vention of disease a nd meeting the above definitio n. | |
6 | NOTE: A ph ysician ma y use a ma rketed dru g in an un approved m anner in a n individu al patient without r equiring a clinical study prot ocol or ob taining an IND for t herapeutic , rather t han invest igational purposes ( Title 21 C FR § 312.2 [d]) (see VA’s Off L abel Drug Use Guidan ce at: | |
7 | http:// :PORT /directive /Guidance% 20Off%20La bel%20Pres cribing.pd f ) | |
8 | This is an internal Web site a nd is not available to the pub lic. The V eterans In tegrated S ervice Net work (VISN ) Therapeu tics Manag ement Comm ittee, the Chief of Staff, or the medica l facility Director may apply more strin gent contr ols regard ing such d rug usage. | |
9 | (2) Concur rent medic ations, co mparators, or rescue medicatio ns used in the inves tigational trial tha t are not the drug(s ) being st udied are not define d as inves tigational drugs, un less they are not co mmercially approved or not ava ilable thr ough comme rcial chan nels. | |
10 | NOTE: The preceding definition s also app ly to drug s used for animal re search tha t are stor ed in and/ or supplie d through pharmacy. | |
11 | Investigat ional New Drug (IND) Applicati on: An IND applicati on is an a pplication to the FD A that all ows an inv estigation al drug or biologica l product to be stud ied in hum ans. An IN D applicat ion must b e in effec t prior to shipment and admini stration o f investig ational dr ugs or bio logical pr oducts (se e 21 CFR 3 12). | |
12 | When appro priate a V A Form 10- 9012 can b e attached in the Re search Stu dy Applica tion. The PI upload to the VA form 10-90 12 in the Research Study Appl ication. T he PI is a ble to do so in sect ion G, que stion 8 an d question 9 of the Research S tudy Appli cation. Th e PI may a lso use th e VA Form 10-9012 te mplate tha t is readi ly availab le for use . This tem plate can be accesse d using th e link ava ilable in Section G question 9 . Please s ave sectio n G before generatin g the temp late. Afte r clicking the link, a documen t ribbon i s generate d with Ope n or Cance l option. A copy of this templ ate also g ets saved in the att achment se ction of t he Applica tion. The PI may cho ose to ope n the temp late and s tart makin g updates to the tem plate or m ay choose to cancel to update it at a la ter time. Any change s saved to the docum ent after the genera tion of th e template will be s aved to th e attached document. The PI ac cess the d ocument by navigatin g to the A ttachment section of the appli cation. |
Araxis Merge (but not the data content of this report) is Copyright © 1993-2016 Araxis Ltd (www.araxis.com). All rights reserved.