Graham Ball

Standard operating procedures for clinical research personnel ‐ Part 16

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

Standard Operating Procedures for clinical research personnel – Part 15

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

Standard operating procedures for clinical research personnel – Part 11

This is the eleventh 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 selection of CROs (SOP 326) and selection of clinical laboratories (SOP 327). (The full text of all 101 SOPs is available from the authors.) Copyright

Standard Operating Procedures for Clinical Research Personnel ‐ part 13

This is the 13th 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 initiation activities: study site initiation visits (SOP 328); and study startup meetings for multicentre studies ( SOP 329). (The full text of all 101 SOPs is available from the authors.) Copyright

Standard operating procedures for clinical research personnel—part 6

This is the sixth 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, three SOPs for the management of investigator brochures including preparation (SOP 301), review, approval and amendment (SOP 302) and distribution (SOP 303) are addressed. A sample of the format and contents of an investigator brochure is also included. (The full text of all 101 SOPs is available from the authors.) Copyright

Standard operating procedures for clinical research personnel—Part 7

This is the seventh 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 Organizations (CROs). The procedures include those required by the International Conference on Harmonization (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 the management of protocols and protocol amendments including preparation and format (SOPs 304 and 307), review, approval and amendment (SOPs 305 and 308) and distribution (SOPs 306 and 309). (The full text of all 101 SOPs is available from the authors.) Copyright

Standard operating procedures for clinical research personnel – part 9

This is the ninth 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 the initial selection process for suitable study sites (SOP 315), study site selection visits (SOP 316), assessment of Phase I facilities (SOP 317), documentation of qualifications of investigators and other site personnel (SOP 318) and final authorisation to use a study site (SOP 319). (The full text of all 101 SOPs is available from the authors.) Copyright

Standard operating procedures for clinical research personnel – part 8

This is the eighth 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 the management of case report forms (CRFs) including preparation (SOP 310), review, approval and amendment (SOP 311) and printing and distribution (SOP 312). SOPs are also presented for compilation of documents for submission to regulatory authorities (SOP 313) and documentation of review and approval by regulatory authorities. (The full text of all 101 SOPs is available from the authors.) Copyright

Standard operating procedures for clinical research personnel—part 4

This is the fourth in a series of articles containing proposals for the wording and content of standard operating procedures (SOPs) for clinical research activities conducted by sponsors and contract research organizations (CROs). The procedures include those required by the International Conference on Harmonization (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and ‘best practice’ observed by the authors. The model forms obviously require modification for actual use. (The full text of all 101 SOPs is available from the authors). Copyright

Standard operating procedures for clinical research personnel—part 1

This is the first in a series of articles containing proposals for the wording and content of Standard Operating Procedures (SOPs) for clinical research activities conducted by sponsors and Contract Research Organizations (CROs). The procedures include those required by the International Conference on Harmonization (ICH), the Food and Drug Administration (FDA), many other guidelines and regulations, and ‘best practice’ observed by the authors. The model forms obviously require modification for actual use. Copyright