The Experts below are selected from a list of 303 Experts worldwide ranked by ideXlab platform
Graham Ball - One of the best experts on this subject based on the ideXlab platform.
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Standard Operating Procedures for clinical Research Personnel ‐ part 23
The Quality Assurance Journal, 2005Co-Authors: Wendy Bohaychuk, Graham BallAbstract:This is the twenty-third and final part in a series of articles containing proposals for wording and content of Standard Operating Procedures (SOPs) for clinical Research activities conducted by Sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and ‘best practice’ observed by the authors. The model forms require modification for actual use. In this article, more SOPs are presented for final activities for closure of a clinical study: preparation of clinical study reports (SOP 703); review, approval and amendment of clinical study reports (SOP 704); distribution of clinical study reports (SOP 705); general procedures for archiving clinical study documents (Sponsors/CROs) (SOP 706); and general procedures for archiving clinical study documents (study sites) (SOP 707). (The full text of all 101 SOPs is available from the authors.) Copyright © 2005 John Wiley & Sons, Ltd.
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Standard operating procedures for clinical Research Personnel--Part 17
The Quality Assurance Journal, 2003Co-Authors: Wendy Bohaychuk, Graham BallAbstract:This is the 17th in a series of articles containing proposals for wording and content of Standard Operating Procedures (SOPs) for clinical Research activities conducted by sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and 'best practice' observed by the authors. The model forms require modification for actual use. In this article, SOPs are presented for management of study medications/devices: initial request for study medications/devices (SOP 501); labelling and packaging of study medications/devices (SOP 502) and shipment of study medications/devices to study sites (SOP 503). (The full text of all 101 SOPs is available from the authors.) Copyright © 2003 John Wiley & Sons, Ltd.
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Standard operating procedures for clinical Research Personnel – Part 18
The Quality Assurance Journal, 2003Co-Authors: Wendy Bohaychuk, Graham BallAbstract:This is the 18th in a series of articles containing proposals for wording and content of Standard Operating Procedures (SOPs) for clinical Research activities conducted by sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and 'best practice' observed by the authors. The model forms require modification for actual use. In this article, SOPs are presented for management of study medications/devices: receipt of study medications/devices at study sites ( SOP 504); control of study medications/devices at study sites (SOP 505); assessment of compliance with use of study medications/devices (SOP 506) and return of study medications/devices from study sites (SOP 507). (The full text of all 101 SOPs is available from the authors.) Copyright © 2003 John Wiley & Sons, Ltd.
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Standard operating procedures for clinical Research Personnel ‐ Part 16
The Quality Assurance Journal, 2003Co-Authors: Wendy Bohaychuk, Graham BallAbstract:This is the 16th in a series of articles containing proposals for wording and content of Standard Operating Procedures (SOPs) for clinical Research activities conducted by sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and ‘best practice’ observed by the authors. The model forms require modification for actual use. In this article, SOPs are presented for internal review of case report forms and data: initial internal CRF review (after retrieval to sponsor/CRO) (SOP 405); data correction after retrieval from study sites (SOP 406); database development, review and lock (SOP 407); and statistical review (SOP 408). SOPs are also presented for management of CROs (SOP 409) and clinical laboratories during studies (SOP 410). (The full text of all 101 SOPs is available from the authors.) Copyright © 2003 John Wiley & Sons, Ltd.
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Standard Operating Procedures for clinical Research Personnel – Part 15
The Quality Assurance Journal, 2003Co-Authors: Wendy Bohaychuk, Graham BallAbstract:This is the 15th in a series of articles containing proposals for wording and content of Standard Operating Procedures (SOPs) for clinical Research activities conducted by sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and ‘best practice’ observed by the authors. The model forms require modification for actual use. In this article, SOPs are presented for review of source documents and case report forms: source documents versus Case Report Forms [CRFs] (SOP 403) and source data verification and CRF review at study sites (SOP 404). (The full text of all 101 SOPs is available from the authors.) Copyright © 2003 John Wiley & Sons, Ltd.
Wendy Bohaychuk - One of the best experts on this subject based on the ideXlab platform.
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Standard Operating Procedures for clinical Research Personnel ‐ part 23
The Quality Assurance Journal, 2005Co-Authors: Wendy Bohaychuk, Graham BallAbstract:This is the twenty-third and final part in a series of articles containing proposals for wording and content of Standard Operating Procedures (SOPs) for clinical Research activities conducted by Sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and ‘best practice’ observed by the authors. The model forms require modification for actual use. In this article, more SOPs are presented for final activities for closure of a clinical study: preparation of clinical study reports (SOP 703); review, approval and amendment of clinical study reports (SOP 704); distribution of clinical study reports (SOP 705); general procedures for archiving clinical study documents (Sponsors/CROs) (SOP 706); and general procedures for archiving clinical study documents (study sites) (SOP 707). (The full text of all 101 SOPs is available from the authors.) Copyright © 2005 John Wiley & Sons, Ltd.
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Standard operating procedures for clinical Research Personnel ‐ Part 21
The Quality Assurance Journal, 2004Co-Authors: Wendy Bohaychuk, C D Graham BallAbstract:This is the 21st in a series of articles containing proposals for wording and content of standard operating procedures (SOPs) for clinical Research activities conducted by sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and ‘best practice’ observed by the authors. The model forms require modification for actual use. In this article, SOPs are presented for management of safety events: recording and reporting serious adverse events (SOP 603); and reporting safety information externally (SOP 604). (The full text of all 101 SOPs is available from the authors.) Copyright © 2004 John Wiley & Sons, Ltd.
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Standard operating procedures for clinical Research Personnel ‐ Part 20
The Quality Assurance Journal, 2004Co-Authors: Wendy Bohaychuk, C D Graham BallAbstract:This is the twentieth in a series of articles containing proposals for wording and content of Standard Operating Procedures (SOPs) for clinical Research activities conducted by sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and 'best practice' observed by the authors. The model forms require modification for actual use. In this article, SOPs are presented for management of safety events: definitions for assessing safety events and sources of safety information (SOP 601); recording and reporting adverse events (SOP 602). (The full text of all 101 SOPs is available from the authors.) Copyright © 2004 John Wiley & Sons, Ltd.
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Standard operating procedures for clinical Research Personnel – Part 19
The Quality Assurance Journal, 2004Co-Authors: Wendy Bohaychuk, C D Graham BallAbstract:This is the nineteenth in a series of articles containing proposals for wording and content of standard operating procedures (SOPs) for clinical Research activities conducted by sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and ‘best practice’ observed by the authors. The model forms require modification for actual use. In this article, SOPs are presented for management of study medications/devices and randomisation procedures: final disposition of study medications/devices (SOP 508); recall of investigational products (SOP 509); reallocation of investigational products between study sites (SOP 510); requesting and preparing randomisation schedules (SOP 511); revealing randomisation code assignments during studies (SOP 512) and revealing randomisation code assignments after study completion (SOP 513). (The full text of all 101 SOPs is available from the authors.) Copyright © 2004 John Wiley & Sons, Ltd.
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Standard Operating Procedures for clinical Research Personnel ‐ Part 22
The Quality Assurance Journal, 2004Co-Authors: Wendy Bohaychuk, Ball C. D. GrahamAbstract:This is the twenty-second part in a series of articles containing proposals for wording and content of Standard Operating Procedures (SOPs) for clinical Research activities conducted by Sponsors and Contract Research Organisations (CROs). The procedures include those required by the International Conference on Harmonisation (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and ‘best practice’ observed by the authors. The model forms require modification for actual use. In this article, SOPs are presented for final activities for closure of a clinical study: study site closure (SOP 701) and premature termination or suspension of clinical studies (SOP 702). More SOPs related to study closure will appear in the next issue of QAJ. (The full text of all 101 SOPs is available from the authors.) Copyright © 2004 John Wiley & Sons, Ltd.
Christine B. Brezden - One of the best experts on this subject based on the ideXlab platform.
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Barriers to patient accrual in Ontario oncology clinical trials: Attitudes of oncologists and clinical Research Personnel.
Journal of Clinical Oncology, 2012Co-Authors: Ammar Bookwala, Daisy Dastur, Audrey Wong, Christina Marchand, Jalal Ebrahim, Sophie Hogeveen, Ata Ansari, Laura Sevick, Christine B. BrezdenAbstract:36 Background: The medical specialty of oncology relies heavily on clinical trials to advance policies and practices related to cancer care. However, oncology clinical trial accrual in Ontario has dropped from 12.4% in 2007, to 8.5% in 2009. The objective of this study was to determine barriers experienced by Oncologists and Clinical Research Personnel (CRP) in recruiting patients to oncology trials in Ontario. Methods: In June 2012, an electronic survey was emailed to about 400 oncologists and CRP across Ontario. Variables of interest included demographic data, clinical trial involvement, and perceived barriers to participation in clinical trials amongst three previously identified barrier domains. Barriers were ranked, from 1 (least significant) to 5 (most significant). Statistics were compiled using Graphpad Prism software. Differences in responses were analyzed using the Kruskal – Wallis test and Dunn’s Multiple Comparison Test. Results: Of the 400 emails sent, there were 126 respondents (32%). Of the...
Linjia Zhao - One of the best experts on this subject based on the ideXlab platform.
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Research resources and scientific outputs in China: Based on a survey data
2016 Portland International Conference on Management of Engineering and Technology (PICMET), 2016Co-Authors: Dasheng Deng, Hui Shi, Linjia ZhaoAbstract:Based on a nationwide survey data on Chinese Research Personnel, this paper analyzes the status of Research resource acquisition and the influential factors of the number of papers published. The statistic results show that the Research Personnel, with doctoral degree and senior professional title, have obvious advantages to acquire Research resources. Moreover, possession of more resources significantly increases the total number of published papers, while age, gender, and administrative post are not statistically significant in the regression model.
Ammar Bookwala - One of the best experts on this subject based on the ideXlab platform.
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Barriers to patient accrual in Ontario oncology clinical trials: Attitudes of oncologists and clinical Research Personnel.
Journal of Clinical Oncology, 2012Co-Authors: Ammar Bookwala, Daisy Dastur, Audrey Wong, Christina Marchand, Jalal Ebrahim, Sophie Hogeveen, Ata Ansari, Laura Sevick, Christine B. BrezdenAbstract:36 Background: The medical specialty of oncology relies heavily on clinical trials to advance policies and practices related to cancer care. However, oncology clinical trial accrual in Ontario has dropped from 12.4% in 2007, to 8.5% in 2009. The objective of this study was to determine barriers experienced by Oncologists and Clinical Research Personnel (CRP) in recruiting patients to oncology trials in Ontario. Methods: In June 2012, an electronic survey was emailed to about 400 oncologists and CRP across Ontario. Variables of interest included demographic data, clinical trial involvement, and perceived barriers to participation in clinical trials amongst three previously identified barrier domains. Barriers were ranked, from 1 (least significant) to 5 (most significant). Statistics were compiled using Graphpad Prism software. Differences in responses were analyzed using the Kruskal – Wallis test and Dunn’s Multiple Comparison Test. Results: Of the 400 emails sent, there were 126 respondents (32%). Of the...
