Bioequivalence and Bioavailability Forum • Re-consenting volunteers?

Re-consenting volunteers? [Off Topic]

posted by Ohlbe – France, 2016-06-23 06:51 (2856 d 22:46 ago) – Posting: # 16447
Views: 35,940

Dear Nobody,

❝ ❝ This gives some idea on how well these guys know and understand our laws and regulations governing clinical trials.

❝

❝ ...if you outsource, you outsource, I don't think that the sponsor can be aware of all local regulations, the CRO should provide the sponsor in the protocol with all his obligations according to local laws. My opinion!

"These guys" in my sentence above did not refer to either the sponsor or Biotrial, but to the IGAS inspectors who perpetrated this report.

—
Regards
Ohlbe

Complete thread:

Death in phase I cannabinoid? nobody 2016-01-15 16:49
- Death in phase I cannabinoid? Helmut 2016-01-15 17:25
  - Death in phase I cannabinoid? nobody 2016-01-15 17:45
    - Death in phase I cannabinoid? Helmut 2016-01-15 17:48
      - Death in phase I cannabinoid? nobody 2016-01-15 18:02
      - Structure Ohlbe 2016-01-18 13:42
        
        Structure nobody 2016-01-28 15:29
  - Death in phase I cannabinoid? Ohlbe 2016-01-18 09:58
    - Death in phase I cannabinoid? nobody 2016-01-18 15:07
- Protocol Ohlbe 2016-01-22 17:18
  - Protocol nobody 2016-01-23 18:37
    - Protocol Ohlbe 2016-01-28 12:16
      - Protocol ElMaestro 2016-01-28 15:07
        
        Protocol nobody 2016-01-28 15:40
        
        FIM / FIH Helmut 2016-01-28 17:10
        
        FIM / FIH nobody 2016-01-28 17:55
        
        There is something rotten in the state... nobody 2016-02-26 21:05
        
        Rotten or not rotten ? Ohlbe 2016-02-27 05:49
        
        Rotten or not rotten ? nobody 2016-02-27 10:56
        
        Rotten or not rotten ? Ohlbe 2016-02-27 14:00
        
        Rotten.. nobody 2016-04-25 17:21
        
        Blame game... nobody 2016-05-23 12:27
        
        FDA: "unique toxiciy" nobody 2016-08-15 16:38
      - Chronology - English version Ohlbe 2016-01-29 18:30
        
        Chronology - English version Helmut 2016-01-29 19:04
        
        Administrative inspection preliminary outcome Ohlbe 2016-02-04 23:30
- Re-consenting volunteers? ElMaestro 2016-06-21 16:42
  - Re-consenting volunteers? Ohlbe 2016-06-22 05:06
    - Re-consenting volunteers? nobody 2016-06-22 11:26
      - Re-consenting volunteers?Ohlbe 2016-06-23 04:51
        
        Re-consenting volunteers? ElMaestro 2016-06-23 08:23
        
        Re-consenting volunteers? nobody 2016-06-23 10:36
        OT: strike d_labes 2016-06-23 11:31
        
        OT: strike Helmut 2016-06-23 13:01
- Paper in the NEJM Ohlbe 2016-11-03 12:21
- Death in phase I cannabinoid? nobody 2017-06-09 10:01