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SoCRA Questions and Answers (Q&A)

John Adney
Answered: Feb 24, 2017
§ 50.27 Documentation of informed consent.

(2) A short form written consent document stating that the elements of informed consent required
by § 50.25 have been presented...Read More

7 Answers

259 views
I.Elizabeth
Answered: Feb 02, 2018
There are many side effects or harmful consequences of manipulating with the body. Influencing the systems is not without problems. Normally, when there is an unfavorable sign or something...Read More

2 Answers

242 views
Wyatt Williams
Answered: Mar 28, 2020
Disclosure - Financial Interests and Agreements of Clinical Investigators

1 Answer

239 views
Wyatt Williams
Answered: Mar 28, 2020
Certification - Financial Interests and Arrangements of Clinical Investigators

1 Answer

217 views
Eileen B McKee
Answered: Nov 08, 2017
56.108 IRB functions and operations. 109 is Review of Resear...Read More

6 Answers

215 views
John Smith
Answered: Mar 28, 2020
A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject s participation, a description of the procedures to be followed,...Read More

4 Answers

212 views
Wyatt Williams
Answered: Mar 28, 2020
Exception from General Requirements

2 Answers

211 views
Wyatt Williams
Answered: Mar 28, 2020
Exception from Informed Consent Requirements for Emergency Research

1 Answer

211 views
Markda John
Answered: Jan 02, 2018
This is the definition of the Good Clinical Practice, or GCP, guidelines. It’s basically guidelines that anyone seeking to do human trials of a drug has to follow. These rules will ensure...Read More

3 Answers

210 views
John Smith
Answered: Mar 28, 2020
Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects disorder or...Read More

1 Answer

210 views
Wyatt Williams
Answered: Mar 28, 2020
Documentation of informed consent

1 Answer

209 views
Bgumby
Answered: Mar 28, 2020
Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects disorder or...Read More

1 Answer

208 views
John Smith
Answered: Mar 28, 2020
Clinical Investigations not involving greater than minimal risk - children

Remember - all sections under subpart D of 21CFR50 deal with children - the heading for all of subpart D is...Read More

1 Answer

208 views
Eileen B McKee
Answered: Nov 08, 2017

§ 56.106 Registration.
(copied & pasted from SoCRA Ref. Manual

3 Answers

207 views

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