Outsourced Study Sample Timeline

STUDY PLANNING CHECKLIST AND SAMPLE TIMELINE FOR PRE- AND POST-STUDY ACTIVITIES

Activity

T-50

T-40

T-30

T-20

T-10

In-Life Phase

T+10

T+20

T+30

T+40

T+50

T+60

T+70

a) Initial planning T-50
b) Confidentiality agreement
c) Request for draft quote T-50
d) Approval of draft quote T-45
e) Initial study plan T-30
1) Analysis of dose solutions (method and schedule)
2) Animal husbandry
3) Health/safety
4) Test and control article handling and storage
5) Supplies
6) Dosing: route of administration, regimen, duration
7) Dose preparation
8) Clinical operations
9) Necropsy/gross pathology
10) Clinical chemistry parameters
11) Histopathology parameters
12) Analysis of data (statistics)
f) Draft study protocol  T-28
1) Sponsor review
2) IACUC review
3) QA review
g) Set pre-study meeting date (CRO staff) T-28
h) Pre-study Sponsor—CRO meeting (preferably in person, or by video  or teleconference)  T-14
1) Appropriate staff
a) Sponsor company:  technical contact, admin contact, other
b) CRO: technical management, study director, QA, admin
2) Review and clarify: protocol, study background, deadlines
i) Protocol approval T-10
j) Sponsor transfers test article to CRO T-3
k) Sponsor and QA review draft report T+29 to T+50
l) Sponsor receives final report T+60
m) Team review/evaluation with CRO T+70

Download printable version of our booklet Preclinical Toxicology – Points to Consider in Program Design (PDF).

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