Can we use in other study- earlier screened but not enrolled [GxP / QC / QA]
Dear Madam/Sir,
In a BA/BE setup, usually companies have screening and study specific ICF to make sure that they screen large number of volunteers so that they can be enrolled in the studies with in 21 days from screening. If the company has one single ICF which talks about both screening and study specifics and they screen 50 volunteers but study requires 20 volunteers. Can we put remaining 30 screened volunteers in another study after reconsenting for the other study without screening them within 21 days.
Kindly suggest.
Thanks and regards,
In a BA/BE setup, usually companies have screening and study specific ICF to make sure that they screen large number of volunteers so that they can be enrolled in the studies with in 21 days from screening. If the company has one single ICF which talks about both screening and study specifics and they screen 50 volunteers but study requires 20 volunteers. Can we put remaining 30 screened volunteers in another study after reconsenting for the other study without screening them within 21 days.
Kindly suggest.
Thanks and regards,
Complete thread:
- Can we use in other study- earlier screened but not enrolledraghavendra_s 2010-05-25 09:15
- Can we use already screened leftover subjects in other study bharat 2010-05-25 11:51
- Dr. Mengele Helmut 2010-05-25 11:56
- Dr. Mengele raghavendra_s 2010-05-25 15:46
- Dr. Mengele Helmut 2010-05-25 17:01
- Dr. Mengele raghavendra_s 2010-05-25 15:46
- Can we use already screened leftover subjects in other study YT 2010-05-25 12:06