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Summary Report of the Inspections of Clinical Trials Conducted in 2003 / 2004
| Regulations | Number of observations | Brief description of the section / sub-section of the Regulations, Division 5 - Food and Drug Regulations "Drugs for clinical trials involving human subjects" | General classifi-cation of deficiency |
Frequency % |
|||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Total number of observations | Qualified Investigators | Research Ethics Board (REB) | |||||||||
| Commercial Sponsor | Non Commercial Sponsor | ||||||||||
| % | % | % | % | ||||||||
| C.05.001 | 3 |
0 |
0 |
3 |
11 % |
Membership of Research Ethics Board | |||||
| C.05.003 | 3 |
0 |
3 |
0 |
General prohibition | ||||||
| C.05.008(1) | 8 |
3 % |
2 |
4 |
2 |
Amendments approved by Research Ethics Board (REB) and Health Canada | |||||
| C.05.010(a) | 5 |
2 |
3 |
0 |
Protocol clearly described | Protocol |
10 % |
||||
| C.05.010(b) | 23 |
8 % |
11 |
10 % |
12 |
8 % |
0 |
Clinical trial conducted in accordance with protocol and Regulations | |||
| C.05.010(c) | 68 |
23 % |
23 |
20 % |
34 |
22 % |
11 |
40 % |
Quality systems and procedures in place for all aspects of the trial | Quality Systems |
23 % |
| C.05.010(d) | 3 |
1 |
1 |
1 |
Approval by REB before initiation of trial | ||||||
| C.05.010(e) | 4 |
1 |
3 |
0 |
No more than one Qualified Investigator per site | ||||||
| C.05.010(f) | 7 |
2 % |
1 |
4 |
2 |
Medical care under supervision of Qualified Investigator | |||||
| C.05.010(g) | 9 |
3 % |
3 |
3 % |
6 |
4 % |
0 |
Qualifications education and training | |||
| C.05.010(h) | 59 |
20 % |
25 |
22 % |
32 |
21 % |
2 |
Informed consent obtained in accordance with applicable laws | Informed Consent Process |
20 % |
|
| C.05.010(j) | 18 |
6 % |
6 |
12 |
8 % |
0 |
Drug manufactured, handled, stored in accordance with applicable Good Manufacturing Practices. Includes Labelling C.05.011 | ||||
| C.05.012(1) | 44 |
15 % |
25 |
22 % |
19 |
13 % |
0 |
Record, handle, and storage of all information | Records |
28 % |
|
| C.05.012(2) | 12 |
4 % |
6 |
2 |
4 |
15 % |
Maintain complete and accurate records to establish that trial conducted in accordance with Good Clinical Practices | ||||
| C.05.012(3)(c) | 5 |
1 |
3 |
1 |
Adverse events reporting. Includes C.05.014 (Serious and unexpected) | ||||||
| C.05.012(3)(e) | 4 |
2 |
2 |
0 |
Drug accountability | ||||||
| C.05.012(3)(f) | 7 |
1 |
6 |
0 |
Undertaking by the Qualified Investigator. Includes C.05.005(c)(ix) Name of Qualified Investigator at every site. | ||||||
| C.05.012(4) | 10 |
3 % |
3 |
6 |
1 |
Records to be maintained for 25 years | |||||
| Total | 292 |
113 |
39 % |
152 |
52 % |
27 |
9 % |
||||
