krish
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India,
2014-12-29 13:23
(3396 d 02:18 ago)

Posting: # 14199
Views: 3,994
 

 Informed consent [GxP / QC / QA]

Dear All,

The Additional essential element 2 as per 21 CFR part 50 is,

Any additional costs to the subject resulted from study participation.

Can any please let me know what would be the types of additional costs the subject may have to bear while participating in the trail.


thanks and regards,

KRISH


Edit: Category changed. [Helmut]
Helmut
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Vienna, Austria,
2014-12-29 16:21
(3395 d 23:20 ago)

@ krish
Posting: # 14201
Views: 3,120
 

 Additional costs to the subject

Hi Krish,

❝ The Additional essential element 2 as per 21 CFR part 50 is,


I guess you mean CFR 21 Title 21, Volume 1, Part 50, Section 50.25(b)(3)

❝ Can any please let me know what would be the types of additional costs the subject may have to bear while participating in the trail.


Examples: Travel expenses to and from the clinical site, compensation for unpaid leave of absence…

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