August 2024 SOCRA Source Journal - Journal - Page 24
When technology is done
right, however, it can be a
game changer. Technology
can improve the daily work
lives and morale of clinical
research site staff. The key is to
understand the tradeoffs and
the experience.
In order for technology to
be a game changer, more
collaboration is required
between clinical research sites
and sponsors. When sites
struggle, sponsors struggle.
Sponsors know this. As new
technology solutions come
forward, sites and sponsors
must determine whether the
solutions are really game
changers and not creating more
burden and nightmares.
The best way for research teams
to help ensure that technology
solutions are game changers
is to use their voice to shape
the technology of tomorrow.
Ways for research teams to
do this include posting and
commenting on LinkedIn,
having conversations with
clinical research associates when
working together on a study,
and discussing technology
with sponsors at conferences.
There has been a shift in the
clinical research industry from
pharmaceutical companies
making decisions on behalf
of clinical research sites to
sponsors wanting to understand
what is and is not working
and collaborating on building
the technology solutions of
tomorrow.
SELF STUDY ANSWER KEY
Informed Consent
Guidance for IRBs, Clinical Investigators, and Sponsors
ANSWERS
24
1.
b. False (Section A.2)
7.
d. all the above (Section A.1)
2.
c. bene昀椀ts (Section A.3)
8.
d. all the above (Section A.1)
3.
a. 50.25(a)(7) (Section A.7)
9.
4.
b. False (Section B.3/Footnote 38)
5.
a. True (Section B.6)
b. Risks and discomforts, voluntary
participation, bene昀椀ts, and alternatives
(Section A.2, 3, 4, and 8)
6.
c. both a. and b. (Section A.3)
SOCRA SOURCE © May 2024
10. b. False (Section A.4)