{"id":2498,"date":"2015-04-03T17:59:52","date_gmt":"2015-04-03T17:59:52","guid":{"rendered":"http:\/\/www.staging-protocolbuilderpro.kinsta.cloud\/?p=2498"},"modified":"2022-01-13T14:30:58","modified_gmt":"2022-01-13T14:30:58","slug":"common-protocol-development-errors-part-two","status":"publish","type":"post","link":"https:\/\/protocolbuilderpro.com\/common-protocol-development-errors-part-two\/","title":{"rendered":"Common Protocol Development Errors\u00a0(Part\u00a0Two)\u00a0"},"content":{"rendered":"

[vc_row css_animation=”” row_type=”row” use_row_as_full_screen_section=”no” type=”full_width” angled_section=”no” text_align=”left” background_image_as_pattern=”without_pattern”][vc_column][vc_column_text]In this,\u00a0the second in a three-part series, we will look at the typical types of information or documentation that may be missing in\u00a0investigator-initiated\u00a0protocol submissions\u00a0to an IRB.<\/p>\n

Subject Recruitment and\u00a0<\/b>Informed consent<\/b>[\/vc_column_text][vc_empty_space height=”12px”][vc_column_text]Some investigators are unclear about what to include in a\u00a0research\u00a0protocol vs. what is supplementary information. For example,\u00a0some investigators may consider recruitment materials to be supplementary information. However,\u00a0a\u00a0complete\u00a0protocol should\u00a0specify the\u00a0\u201crecruitment plan,\u201d describing\u00a0how potential subjects will be identified and contacted. This description\u00a0should contain details about how, when, where and by whom\u00a0identified individuals will be\u00a0approached about possible participation in the study.<\/p>\n

If, for example, the investigator needs to access medical records to identify potential subjects,\u00a0the need to access protected health information (PHI) prior to obtaining consent and authorization need to be considered. The IRB or privacy board may need to grant\u00a0a\u00a0partial\u00a0HIPAA waiver\u00a0to allow access to the records\u00a0if the investigator is not\u00a0a member of the work force of the organization that has the medical records.\u00a0A protocol containing a detailed recruitment plan will help investigators and the IRB to identify and facilitate approval of the procedures that will be necessary to carry out the research.\u00a0It is helpful if investigators include all the subject recruitment materials\u2014emails, phone scripts, advertisements, flyers, and so on.<\/p>\n

Investigators must be explicit about the process\u00a0for obtaining\u00a0informed consent.\u00a0Who will obtain consent, and in what setting will the consent discussion occur?<\/p>\n

IND and IDE<\/b><\/p>\n

Another reason that protocols may not be approved by an IRB is that an IND (investigational new drug) or IDE (investigational device exemption) is missing. Investigators might not always realize the proposed intervention\u00a0may be\u00a0an FDA-regulated clinical investigation.\u00a0All clinical evaluations of investigational devices, unless exempt, must have an approved IDE\u202fbefore<\/b>\u202fthe study is initiated. In the case of an investigator-initiated trial on a drug, a physician must submit a research IND to propose\u00a0studying an unapproved drug, or an approved product for a new indication or in a new patient population.<\/p>\n

 <\/p>\n

Inclusion and Exclusion Criteria<\/b><\/p>\n

Sometimes the inclusion and exclusion criteria\u00a0are\u00a0missing or insufficient for adequate review. IRBs\u00a0require\u00a0these to be explicitly\u00a0listed. All studies,\u00a0even\u00a0those with\u00a0minimal interventions,\u00a0must include\u00a0detailed eligibility\u00a0criteria\u00a0so the intended subject population is clear and the IRB can determine that appropriate safeguards are in place.\u00a0Investigators should avoid vague descriptions, such as \u201csignificant cardiac disease.\u201d Instead, outline specific lab or radiological values.<\/p>\n

 <\/p>\n

Monitoring and compliance<\/b><\/p>\n

Most\u00a0FDA regulated\u00a0research\u00a0must\u00a0also\u00a0include a plan for monitoring and reporting adverse events\u00a0and unanticipated problems. But some protocols are missing\u00a0details about how\u00a0information will be collected and to whom it will be reported.\u00a0Protocols should include details about how adverse events will be reported to other investigators, the IRB, and regulatory agencies. Investigators should also include how those participants will be cared for in the case of a serious adverse event.<\/p>\n

Investigators who are initiating their own trials are responsible for assuring the\u00a0adverse event\u00a0monitoring plan is followed.<\/p>\n

 <\/p>\n

A protocol with missing, incomplete or incorrect information makes it difficult for an IRB to understand the research study objectives, which can lead to increased protocol revisions, and delays in approval and enrolling participants.<\/p>\n

Next week we will post the most common inconsistent elements from a protocol.<\/p>\n

 <\/p>\n

Contact us<\/a> to see how Protocol Builder can help solve protocol development issues and avoid delays.<\/strong>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"

In this, the second in a three-part series, we will look at the typical types of information or documentation that may be missing in investigator-initiated protocol submissions to an IRB.<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[37],"tags":[],"yoast_head":"\nCommon Protocol Development Errors\u00a0(Part\u00a0Two)\u00a0 - Protocol Builder<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/protocolbuilderpro.com\/common-protocol-development-errors-part-two\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Common Protocol Development Errors\u00a0(Part\u00a0Two)\u00a0 - Protocol Builder\" \/>\n<meta property=\"og:description\" content=\"In this, the second in a three-part series, we will look at the typical types of information or documentation that may be missing in investigator-initiated protocol submissions to an IRB.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/protocolbuilderpro.com\/common-protocol-development-errors-part-two\/\" \/>\n<meta property=\"og:site_name\" content=\"Protocol Builder\" \/>\n<meta property=\"article:published_time\" content=\"2015-04-03T17:59:52+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-01-13T14:30:58+00:00\" \/>\n<meta name=\"author\" content=\"Protocol Builder\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Protocol Builder\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/protocolbuilderpro.com\/common-protocol-development-errors-part-two\/\",\"url\":\"https:\/\/protocolbuilderpro.com\/common-protocol-development-errors-part-two\/\",\"name\":\"Common Protocol Development Errors\u00a0(Part\u00a0Two)\u00a0 - 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