IN PARTNERSHIP


The ACTide sourceBOX – details of the dashboard and patient visit.


Benefi ts of the SSFA The rSDV provides faster awareness of issues needing investigation at the site, often prior to the site visit. If an issue is still outstanding once the monitor is on a site visit, this is typically indicative of a larger problem. With the traditional monitoring process, it takes a minimum of two on-site visits – worth up to four months of work – to establish a pattern; with rSDV, a pattern can be established in two to three weeks. The rSDV activities are also helpful in identifying


potentially problematic sites. If the rSDV specialists encounter an excessive proportion of unverifi able data points while performing remote monitoring activities, project leads and clinical monitors can be promptly instructed to collaborate more closely. Site issues can be assessed and resolution actions can be established prior to the scheduled on-site visit.


With improvement of monitoring activities’ quality


and decrease of on-site rework, the rSDV role creates a dual responsibility for each site, which increases accountability. Furthermore, there are signifi cant improvements in the utilisation of the clinical research monitor’s experience. Monitors can now be a valuable resource for the site instead of spending time verifying non-clinical data points. The literature and data analyses conclude that


SDV can still be considered one of many potential quality control methods used to determine whether an acceptable level of accuracy has been achieved in the transcription of critical data. Monitoring methods, such as centralised monitoring, can instead be used to confi rm that the protocol is being followed – improving GCP compliance – and that eligible subjects are enrolled – improving subject safety.●


www.nubilaria.com Outsourcing in Clinical Trials Handbook | 61


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80  |  Page 81  |  Page 82  |  Page 83  |  Page 84  |  Page 85  |  Page 86  |  Page 87  |  Page 88  |  Page 89  |  Page 90  |  Page 91  |  Page 92  |  Page 93  |  Page 94  |  Page 95  |  Page 96  |  Page 97  |  Page 98  |  Page 99  |  Page 100  |  Page 101  |  Page 102  |  Page 103  |  Page 104  |  Page 105  |  Page 106  |  Page 107  |  Page 108  |  Page 109  |  Page 110  |  Page 111  |  Page 112  |  Page 113  |  Page 114  |  Page 115  |  Page 116  |  Page 117  |  Page 118  |  Page 119  |  Page 120