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