Generating evidence on a risk-based monitoring approach in the academic setting – lessons learned

[1] Castle PE(2015)Detection of human papillomavirus 16, 18, and 45 in women with ASC-US cytology and the risk of cervical precancer: results from the CLEAR HPV study Am J Clin Pathol 143 160-167

[2] Cuzick J(2012)The value of source data verification in a cancer clinical trial PLoS One 7 e51623-55

[3] Stoler MH(2014)Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit Trials 15 127-264

[4] Wright TC(2008)Ensuring trial validity by data quality assurance and diversification of monitoring methods Clin Trials 5 49-24

[5] Reid JL(2012)The potential for central monitoring techniques to replace on-site monitoring: findings from an international multi-centre clinical trial Clin Trials 9 257-596

[6] Dockter J(2011)Validation of a risk-assessment scale and a risk-adapted monitoring plan for academic clinical research studies--the Pre-optimon study Contemp Clin Trials 32 16-7

[7] Giachetti C(2009)Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials Clin Trials 6 585-207

[8] Getman D(2009)Quality assurance within the scope of good clinical practice (GCP) – what is the cost of GCP-related activities? a survey within the swedish association of the pharmaceutical industry (LIF)’s members Qual Assur J 12 3-161

[9] Tudur Smith C(1991)EORTC joint ventures in quality control: treatment-related variables and data acquisition in chemotherapy trials Eur J Cancer 27 201-470

[10] Stocken DD(2009)Quality assurance of research protocols conducted in the community: the national institute on drug abuse clinical trials network experience Clin Trials 6 151-412

[1] Castle PE(2015)Detection of human papillomavirus 16, 18, and 45 in women with ASC-US cytology and the risk of cervical precancer: results from the CLEAR HPV study Am J Clin Pathol 143 160-167

[2] Cuzick J(2012)The value of source data verification in a cancer clinical trial PLoS One 7 e51623-55

[3] Stoler MH(2014)Risk-proportionate clinical trial monitoring: an example approach from a non-commercial trials unit Trials 15 127-264

[4] Wright TC(2008)Ensuring trial validity by data quality assurance and diversification of monitoring methods Clin Trials 5 49-24

[5] Reid JL(2012)The potential for central monitoring techniques to replace on-site monitoring: findings from an international multi-centre clinical trial Clin Trials 9 257-596

[6] Dockter J(2011)Validation of a risk-assessment scale and a risk-adapted monitoring plan for academic clinical research studies--the Pre-optimon study Contemp Clin Trials 32 16-7

[7] Giachetti C(2009)Risk analysis and risk adapted on-site monitoring in noncommercial clinical trials Clin Trials 6 585-207

[8] Getman D(2009)Quality assurance within the scope of good clinical practice (GCP) – what is the cost of GCP-related activities? a survey within the swedish association of the pharmaceutical industry (LIF)’s members Qual Assur J 12 3-161

[9] Tudur Smith C(1991)EORTC joint ventures in quality control: treatment-related variables and data acquisition in chemotherapy trials Eur J Cancer 27 201-470

[10] Stocken DD(2009)Quality assurance of research protocols conducted in the community: the national institute on drug abuse clinical trials network experience Clin Trials 6 151-412