{"id":12252,"date":"2019-05-06T12:04:12","date_gmt":"2019-05-06T11:04:12","guid":{"rendered":"http:\/\/gcp.igina.me\/gcp-central-nieuws-nl\/the-wider-impact-of-relevant-gcp-training\/"},"modified":"2019-06-10T13:19:40","modified_gmt":"2019-06-10T12:19:40","slug":"the-wider-impact-of-relevant-gcp-training","status":"publish","type":"post","link":"https:\/\/gcpcentral.com\/nl\/gcp-central-nieuws-nl\/the-wider-impact-of-relevant-gcp-training\/","title":{"rendered":"The wider impact of relevant GCP Training"},"content":{"rendered":"\n

Why is GCP such an important discipline, what impact does it have on clinical trials and why does it\u2019s training need to be relevant and engaging? <\/em><\/strong><\/p>\n\n\n\n

Why is GCP such an important discipline<\/strong><\/h3>\n\n\n\n

#1 <\/strong><\/p>\n\n\n\n

Good Clinical Practice is a guideline written\nby ICH, helping all people supporting the conduct of clinical trials with a\nmedicinal product to deliver high-quality data.<\/p>\n\n\n\n

#2 <\/strong><\/p>\n\n\n\n

The ICH organization brings together health\nregulators and the pharmaceutical industry from all regions. Resulting in the\nharmonization of the requirements for drug development and registration\nworldwide. <\/p>\n\n\n\n

#3<\/strong><\/p>\n\n\n\n

Having high-quality clinical data ensures the\nusability of the clinical data and the safety of the new treatment: whether it\ncan prove a new drug is a better treatment than the current standard, whether\nit is safe to use in humans. The trustworthy, GCP compliant documented data\nenables regulators to review the documented proof of the new treatment and\nallows new drug registrations in their regions. <\/p>\n\n\n\n

GCP knowledge, therefore, is required for all\nstaff working on trials with medicinal products, including nurses documenting\nthe adverse events, laboratory staff analyzing the trial samples, pharmacy\nstaff preparing the administration of the medicines and the data\nmanagers\/medical writers creating the final report for the trial.<\/p>\n\n\n\n

The\nGCP guideline states, <\/p>\n\n\n\n

\u201cStaff have appropriate knowledge, experience and training for the role and responsibilities assigned to them\u201d<\/em><\/strong><\/p><\/blockquote>\n\n\n\n

What Impact on clinical trials and advancements in medicine does GCP have?<\/strong><\/h2>\n\n\n\n

Working according to GCP also enables data to\nbe used and accepted in other regions in the world: official ICH regions are\nEurope, Japan, USA, Brasil, China, Singapore, Korea, Taipei, Canada, and\nSwitzerland. Trials done according to GCP will be accepted by the governments\nof these countries, which helps to spread new treatments for patients around\nthe globe.<\/p>\n\n\n\n

Why is it so important to make GCP training content relevant and engaging? <\/strong><\/h2>\n\n\n\n

GCP is a regulatory guideline, meaning the\ncontent was created by regulators, legal associates and subject matter experts.\n<\/p>\n\n\n\n

Such content is not always easy to read and\nimplement for clinical research professionals. By interviewing research\nprofessionals, we have translated the GCP guideline and local legislation to\nthe day-to-day practice of a research professional. <\/p>\n\n\n\n

Learning about GCP in a recognizable context\nand with the use of active assignments, questions and learning activities\nimproves the retention of the learning material and enables them to use the GCP\nrules they learned in their daily practice. Good quality clinical research is\nthe result. <\/p>\n\n\n\n

The content and scope of the GCP training\nshould be made relevant per role in clinical research, to prevent staff\nlearning inefficiently and getting demotivated by the number of rules they need\nto learn, which they will never use in their job.<\/p>\n\n\n\n

Depending on the delegated activities to a\nstaff member in the trial, the GCP training should be adjusted to explain the\nrequirements for those activities only.<\/p>\n\n\n\n

Sufficient and relevant training keeps staff\nfocused and motivated. Tailoring training to the needs of staff to ensure they\nhave the necessary knowledge for the quality conduct of clinical trials.<\/p>\n\n\n\n

Interestingly, the frequency of GCP Training\nhas not been established by the regulatory bodies, meaning that each\norganization needs to define and set when updates to the training are required,\nwhilst being conscious to changes to GCP regulations or guidance. <\/p>\n\n\n\n

Why are our myGCP users so engaged?<\/h2>\n\n\n\n

Our\nonline training is efficient, flexible and fun. <\/strong><\/p>\n\n\n\n

We allow our students to log in where ever and\nwhenever they like, using their laptop, smartphone or tablet. <\/p>\n\n\n\n

Flexibility is also supported by the modular\nsetup of the course, allowing users to complete learning bites of 10 minutes\nand tracking continuous progress to allow them to start and stop learning\nwhenever they like.<\/p>\n\n\n\n

We offer shorter GCP courses tailored<\/a> to the needs of support staff in clinical trials, making the training efficient and relevant for all. <\/p>\n\n\n\n

Want to know how\nwe can change the future of GCP learning? Sign up for a demonstration here. <\/p>\n","protected":false},"excerpt":{"rendered":"

Why is GCP such an important discipline, what impact does it have on clinical trials and why does it\u2019s training need to be relevant and engaging? <\/p>\n","protected":false},"author":3,"featured_media":12016,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"off","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[54],"tags":[121],"class_list":["post-12252","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gcp-central-nieuws-nl","tag-relevant-gcp-training-nl"],"_links":{"self":[{"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/posts\/12252","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/comments?post=12252"}],"version-history":[{"count":0,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/posts\/12252\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/media\/12016"}],"wp:attachment":[{"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/media?parent=12252"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/categories?post=12252"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/gcpcentral.com\/nl\/wp-json\/wp\/v2\/tags?post=12252"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}