298 ◾ Appendix D: Clinical Trial Process Specification
f. Sign a financial agreement between the sponsor and investigator/
institution.
g. Define the insurance statement.
h. Define the study statement.
i. Define the type of trial: double-blind or placebo controlled.
j. Define the duration time of the trial period.
k. Define the measure method: randomization or binding.
l. Identify data to be recorded.
m. Get approval from the IRB/IEC.
2. Patient recruitment:
a. Work with media.
b. Specify payment method.
c. Address cost of treatment of trial subjects related to injuries.
3. Patient enrollment:
a. Implement patient-enrolled functionalities in the system.
b. Define the duration time of subject participation.