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| Regulations Section / sub-section |
Number of observations Total |
Number of observations Sponsor sites |
Number of observations Qualified Investigator sites |
Brief description of the section / sub-section |
|---|---|---|---|---|
| C.05.010 | 1 | 0 | 1 | Clinical trial conducted according to Good Clinical Practice |
| C.05.010(a) | 1 | 1 | 0 | Protocol clearly described |
| C.05.010(b) | 9 | 1 | 8 | Clinical trial conducted in accordance with protocol and Regulations |
| C.05.010(c) | 21 | 8 | 13 | Quality systems and procedures in place for all aspects of the trial |
| C.05.010(e) | 1 | 0 | 1 | One Qualified Investigator per site |
| C.05.010(g) | 9 | 3 | 6 | Qualification, education and training of staff |
| C.05.010(h) | 12 | 1 | 11 | Informed consent obtained in accordance with applicable laws - subject fully informed |
| C.05.010(j) | 9 | 5 | 4 | Drug to be manufactured according to applicable Good Manufacturing Practices |
| C.05.011 | 1 | 0 | 1 | Labelling requirements |
| C.05.011(c) | 3 | 2 | 1 | Labelling requirements - Expiration date |
| C.05.011(1) | 23 | 2 | 21 | Record, handle, and storage of all information |
| C.05.011(2) | 11 | 1 | 10 | Maintain complete and accurate records to establish that trial conducted in accordance with GCP |
| C.05.011(4) | 7 | 6 | 1 | Records to be maintained for 25 years |
| Total | 108 | 30 | 78 |
