Each policy should contain procedures and a timetable for periodic review.
Standard: All documents designated for periodic review shall be reviewed on a regular basis according to an established agency review schedule. For example, if the agency has determined that a document should be reviewed annually, the agency shall provide evidence that the document is reviewed annually and include a copy of the most recent annual review. Several standards in the accreditation process require that adopted plans, policies and procedures be reviewed and updated at various intervals. In those cases, the agency shall provide evidence that the document was reviewed and updates pursuant to the period specified in the standard. Show
Standards with a review requirement are: 1.4.1 Agency Goals and Objectives 1.6.1 Administrative Policies and Procedures 2.4 Park and Recreation System Master Plan 2.5 Strategic Plan 3.4.2 Community Relations Plan 3.6 Records Management Policy and Procedures 3.6.1 Records Disaster Mitigation and Recovery Plan and Procedures 4.1 Personnel Policies and Procedures Manual 4.1.2 Recruitment Process 4.1.8 Compensation Plan 4.3 Job Analyses for Job Descriptions 4.5 Workforce Health and Wellness Program 4.6.1 Employee Training and Development Program 5.1.1 Comprehensive Revenue Policy 6.1 Recreation Programming Plan 6.2 Program Objectives 6.4 Community Education for Leisure Process 7.1 Parkland Acquisition Procedures 7.2 Area and Facilities Development Policies and Procedures 7.5 Maintenance and Operations Management Standards 7.5.1 Facility Legal Requirements 7.9.1 Recycling and/or Zero Waste Plan 8.5 General Security Plan 8.6.2 Emergency Risk Communications Plan 9.1 Risk Management Policy 10.4 Needs Assessment 10.5.1 Recreation and Leisure Trends Analysis Suggested evidence of compliance: Provide the agency review schedule for the document, program, policy or procedure referenced in the enumerated standards. Agency Evidence of Compliance: Assuming no changes in laws occur necessitating a more frequent review, the following schedule demonstrates the Park District's timetable for review of documents: 9) How to sort the procedures, policies and processes listed on the their dashboard based on when they was last reviewed. Note in the following screenshots examples were taken from the procedure review. However reviewing a policy and process follow the same pattern. Why it is important to schedule a reminder to review.To make sure the content of a procedure, policy or process never gets stale, old or out-of-date, SweetProcess makes it easy to schedule a reminder in the future to review. You and your employees who manage the procedure will automatically be reminded to verify it's content is up-to-date and if not changes can be made accordingly to improve it. This way you can trust the content you find in the procedure by seeing exactly when and who it was last verified by. Jobless rates were lower in November than a year earlier in 235 of the 389 metropolitan areas, higher in 133, and unchanged in 21. Nonfarm payroll employment increased over the year in 95 metropolitan areas and was essentially unchanged in 294. | | | Investigators should consider using this template when developing the Data and Safety Monitoring Plan (DSMP) for clinical studies funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The goal of the DSMP is to provide a general description of a plan that you intend to implement for data and safety monitoring. The DSMP should specify the following:
Note that all sample text should be replaced with the study specific text. There is no need to include sections that are not relevant to the particular study. Please do not use the sample text verbatim. TABLE OF CONTENTS1.0 Study Overview
2.0 Participant Safety
3.0 Reportable Events
4.0 Interim Analysis & Stopping Rules 5.0 Data and Safety Monitoring
6.0 Data Management, Quality Control, and Quality Assurance
1.0 Study Overview1.1 Study DescriptionThis section outlines the overall goal of this project. It also describes the study design, primary and secondary outcome measures/endpoints, sample size/power calculation and target population, inclusion and exclusion criteria. 1.2 Study ManagementThis section includes the proposed participating sites and their responsibilities. In addition, this section should include the planned enrollment timetable (i.e. projected enrollment). 2.0 Participant Safety2.1 Potential Risks and Benefits for ParticipantsThis section outlines the potential risks and benefits of the research for the study participants and for society. It should include a description of all expected adverse events (AEs), the known side effects of the intervention, and all known risks or complications of the outcomes being assessed. 2.1.1 Potential RisksOutline potential risks for study participants including a breach of confidentiality. {Begin sample text} The potential risks to study participants include but are not limited to temporary slight discoloration of the skin after blood draws and pain at the blood draw site. {End sample text} 2.1.2 Potential BenefitsOutline potential benefits for study participants or if there are no direct benefits to the participants. {Begin sample text} The potential benefits to study participants include but are not limited to ongoing nutritional counseling will be provided to all participants. {End sample text} 2.2 Protection Against Study RisksThis section provides information on how risks to participants will be managed. It should specify any events that would preclude a participant from continuing in the study. In general, the format and content of this section are similar to the Human Participants section of the grant application. In addition, this section describes measures to protect participants against study specific risks including the data security to protect the confidentiality of the data. {Begin sample text} The procedures to protect against risks (describe known risks) include (e.g., a safe, hygienic environment for all medical procedures and an experienced, certified staff). {End sample text} 2.2.1 Informed Consent ProcessThis section explains the informed consent process. It should include, but not be limited to, who will be consenting the participant, how and under what conditions will a participant be consented, and that participation is voluntary. The informed consent process should meet the revised Common Rule requirements for consenting. For further details on this requirement, please visit: https://www.ecfr.gov/cgi-bin/text-idx?SID=921afb2e7909a2cf08c5f3ce160a0c96&mc=true&node=se45.1.46_1116. {Begin sample text} Before individuals may participate in any screening procedures, informed consent will be obtained. The study team intends to follow guidelines to ensure that all participants consent obtained will be as informed and voluntary as possible. The potential participant will be informed that participation is voluntary, and he/she has the right to stop at any time. In addition, the informed consent process will meet the revised Common Rule requirements for consenting. These include but are not restricted to: {End sample text} 3.0 Data and Safety Monitoring3.1 DefinitionsThis section should describe how to identify AEs, SAEs and UPs. In the case where the intervention is a Food and Drug Administration (FDA) regulated drug, device or biologic, it should include the FDA definition, grading scale and “study relatedness” criteria of AEs. 3.1.1 Adverse Events (AEs)The definition of adverse event here is drawn from the OHRP guidance (https://www.hhs.gov/ohrp/regulations-and-policy/guidance/reviewing-unanticipated-problems/index.html); for some studies, the ICH E6 definition may be more appropriate. Expected and unexpected AEs should be listed in this section. {Begin sample text} An AE is defined as any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research. {End sample text} 3.1.2 Serious Adverse Events (SAEs)SAEs are a subset of all AEs. {Begin sample text} SAEs are defined as any adverse event temporally associated with subject’s participation in research that meets any of the following criteria: {End sample text} 3.1.3 Unanticipated Problems (UPs)The OHRP definition of UPs can be accessed using the link provided in Section 3.1.1 above. {Begin sample text} UPs can be either AE/SAEs, which are unexpected events that relate directly to participant safety, or protocol deviations that put patient privacy at risk or put patients at risk in some way that does not have an impact on their health and safety. {End sample text} 3.1.4 Protocol DeviationsThis section should include the study definition of protocol deviations and define the events placing the participant at increased risk of harm or compromising the integrity of the safety data. {Begin sample text} A protocol deviation is generally an unplanned excursion from the protocol that is not implemented or intended as a systematic change. {End sample text} 3.2 Collection and Assessment of AEs, SAEs, UPs, and Protocol DeviationsThe section should include who is responsible for collecting these events, how the information will be captured, where the information will be collected from (e.g., medical records, self-reported), and what study form(s) will be used to collect the information (e.g., case report forms, direct data entry). This section should also include what type of information will be collected (e.g., event description, time of onset, assessment of seriousness, relationship to the study intervention, severity, etc.). Note that it is the NIAMS requirement to collect all AEs regardless of the expectedness or relatedness. This section should also describe who is responsible for assessing these events. The individual(s) responsible should have the relevant clinical expertise to make such an assessment (e.g., physician, nurse practitioner, physician assistant, nurse). When assessing AEs and SAEs, the following information should be included:
{Begin sample text} All AEs will be collected from the date the informed consent form is signed until the final study visit. For events that occur between visits, participants are queried on a routine basis about every two weeks post-randomization through their final study visit. {End sample text} 3.3 Reporting of AEs, SAEs, UPs, Protocol Deviations, Serious or Continuing Noncompliance, and Suspension or Termination of IRB ApprovalThis section should describe who is responsible for reporting these events and the roles and responsibilities of each person on the clinical study team who is involved in the safety reporting to the IRB, FDA (if applicable), Monitoring Body, and NIAMS (through the NIAMS Executive Secretary). It should also include the Office for Human Research Protections (OHRP) and FDA reporting requirements. See NIAMS Reportable Events Requirements and Guidelines for more details. 3.3.1 AE Reporting ProceduresAll non-serious AEs (regardless of expectedness or relatedness) are reported to the Monitoring Body and NIAMS (through the NIAMS Executive Secretary) semi-annually or as determined by the NIAMS. {Begin sample text} All AEs are reported in aggregate as part of the routine data and safety monitoring report provided to the Monitoring Body and the NIAMS (through the NIAMS Executive Secretary). AEs are reported to the IRB as part of the continuing review. {End sample text} 3.3.2 SAE Reporting ProceduresAll SAEs (regardless of expectedness or relatedness ) must be reported in an expedited manner to the NIAMS and the Monitoring Body. There may be different timeline for reporting SAE to the IRBs, FDA (if applicable), Monitoring Body and the NIAMS. The timeline for reporting SAEs to the Monitoring Body and NIAMS (through the NIAMS Executive Secretary) is within 48 hours of the investigator becoming aware of the event so that a real time assessment can be conducted, and the outcome shared in a timely manner. {Begin sample text} All SAEs (regardless of expectedness or relatedness ) will be reported to the Monitoring Body and NIAMS (through the NIAMS Executive Secretary) within 48-hours of the investigator becoming aware of the event. The study team will utilize the study specific SAE report form to collect the information and the investigator will conduct and provide an assessment of each event. Other relevant medical information will be completed on all SAEs regardless of expectedness or relatedness. This data will be entered in the study electronic database capture system. {End sample text} 3.3.3 UP Reporting ProceduresAll events that meet the criteria of a UP must be reported in an expedited manner to the NIAMS and the Monitoring Body. There may be different timeline for reporting UPs to the IRBs, OHRP/FDA (if applicable), Monitoring Body, and the NIAMS. The timeline for reporting UPs to the Monitoring Body and NIAMS (through the NIAMS Executive Secretary) is within 48 hours of the investigator becoming aware of the event so that a real time assessment can be conducted, and the outcome shared in a timely manner. {Begin sample text} If UPs occur during the study, they will be reported to the IRB, Monitoring Body, and NIAMS by the study team. The UP report for the Monitoring Body and NIAMS will be completed and submitted to the NIAMS Executive Secretary within 48 hours of the investigator becoming aware of the event. {End sample text} 3.3.4 Protocol Deviation Reporting ProceduresProtocol deviations impacting participant safety are subject to expedited reporting to the Monitoring Body and NIAMS (through the NIAMS Executive Secretary) within 48 hours of the investigator becoming aware of the event so that a real time assessment can be conducted, and the outcome shared in a timely manner. All other events should be reported at the time of the routine DSMB meeting or submission of the safety report. {Begin sample text} Protocol deviations that may impact participant safety will be reported to the Monitoring Body and NIAMS (through the NIAMS Executive Secretary) within 48 hours of the investigator becoming aware of the event. These may include, but are not limited to, the following: {End sample text} 3.3.5 Serious or Continuing NoncomplianceThis section should include the process in place at your institution to capture and report serious or continuing noncompliance. It should include who is responsible for reporting. Serious or continuing noncompliance must be reported to the NIAMS Program Officer and Grants Management Specialist within 3 business days of IRB determination. A copy of the IRB submission and determination must be submitted along with the report to the NIAMS. The guidance on reporting incidents to OHRP should also be followed to provide the timeline of reporting to this regulatory body. {Begin sample text} The study team plans to comply with research regulations and institutional policies and procedures to minimize risk to participant safety and increase adherence to the study protocol. However, if for any reason the study fails to follow the applicable laws, policies, regulations, or the provisions of the IRB-approved research study, it will report the event as a noncompliance (serious or continuing) to all the oversight bodies, including but not limited to the IRB, NIAMS, and OHRP. Per institutional policy, the investigator will report the event to the IRB within 48 hours of becoming aware of the noncompliance. If the IRB makes a determination that the event is a result of noncompliance (either serious or continuing), it will be reported to the NIAMS Program Officer and Grants Management Specialist within 3 business days of IRB determination. A copy of the IRB submission and determination will be submitted along with the report. The OHRP will also be notified within 3 business days of IRB determination. {End sample text} 3.3.6 Suspension or Termination of IRB ApprovalThis section should include the process for reporting study suspension or termination by the IRB. It should also include who is responsible for reporting to the NIAMS, OHRP, and the timeline for reporting of these events. Suspension or termination of IRB approval must include a statement of the reason(s) for the action and must be reported promptly to the NIAMS Program Officer and Grants Management Specialist within 3 business days of receipt by the PI. {Begin sample text} If the IRB suspends or terminates the study, the investigator will adhere to requirements for reporting to all oversight bodies, including but not limited to the NIAMS and OHRP. Suspension or termination of approval will include a statement of the reason(s) for the action and will be reported to the NIAMS Program Officer and Grants Management Specialist within 3 business days of receipt by the PI. The OHRP will also be notified, at the same, within 3 business days of receipt by the PI. {End sample text} 4.0 Interim Analysis & Stopping RulesThis section provides information on planned interim analysis. Interim analysis may be conducted either due to pre-specified stopping rules as outlined in the protocol and at predetermined intervals, or as determined necessary by the Monitoring Body to assess safety concerns or study futility based upon accumulating data. An interim analysis may be performed for safety, efficacy and/or futility, and the reports are prepared by the unmasked study statistician or data coordinating center responsible for generating such reports. Rules for stopping the study, based on interim analysis, should be described. If no interim analysis is planned, this should be noted within this section. {Begin sample text} Interim analysis of the study is planned according to the alpha spending rule [Lan and DeMets, 1994]. The proportion of expected events is considered as the information statistic. The p-values are constructed to maintain the overall study power of 0.05, two-sided. If the test statistic exceeds the boundary, then the study could be considered for early termination due to emerging differences. The interim look is recommended at the end of year one as we expect approximately 50% of the participants followed for at least six months. {End sample text} 5.0 Data and Safety MonitoringThis section identifies the name of the individual or entity responsible for data and safety monitoring, what information will be reviewed, and frequency of such reviews. A brief general introduction regarding data and safety monitoring oversight should be provided in section 5.0, and further details should be provided in the subsequent sections. {Begin sample text} The investigator will be responsible for ensuring participants’ safety on a daily basis and for reporting Serious Adverse Events and Unanticipated Problems to his or her Institutional Review Board, and the NIAMS and the Monitoring Body (through the NIAMS Executive Secretary), and FDA as required. The Monitoring Body will act in an advisory capacity to the NIAMS to monitor participant safety, evaluate the progress of the study, to review procedures for maintaining the confidentiality of data, the quality of data collection, management, and analyses. {End sample text} 5.1 Frequency of Data and Safety MonitoringThis section describes the frequency of data and safety monitoring reviews. As the reviews of reportable events (AEs, SAEs, UPs, and protocol deviations) are included in Section 3, this section should focus on the routine and ad hoc review of the full data and safety monitoring reports. Data and safety monitoring reports are sent to the Monitoring Body and the NIAMS (through the NIAMS Executive Secretary) in advance of the semi-annual meetings and will include a detailed analysis of study progress, data and safety issues. {End sample text} 5.2 Content of Data and Safety Monitoring ReportThis section describes the content of the data and safety monitoring reports. The specifics of the study and the requests of the Monitoring Body will guide requirements for additional tables and listings. Tables for multi-site studies will present aggregated data as well as data by site. {Begin sample text} The study statistician prepares reports that list adverse events, serious adverse events, deaths, and disease-or intervention-specific events required for Monitoring Body review in order to ensure good clinical care and identify any emerging trends. Demographic data will include sex, ethnicity, race, education, and age, and will be stratified by site. {End sample text} 5.3 Monitoring Body Membership and AffiliationThis section includes a roster of the Monitoring Body’s name(s) and affiliation(s). For studies with a NIAMS-appointed Monitoring Body, the NIAMS Executive Secretary will provide the name(s) and affiliation(s) of the individual(s) serving once the Monitoring Body has been assembled. However, if this is an Internally-appointed Monitoring Body (i.e., PI-appointed), the study team should enter the information in this section once the NIAMS has confirmed that no conflicts of interest with the Monitoring Body member(s) are identified. {Begin sample text} The following individuals have accepted positions as part of the NIAMS-appointed DSMB. {End sample text} 5.4 Conflict of Interest for Monitoring BodiesThis section describes the conflict of interest procedure for Monitoring Body members. For studies with a NIAMS-appointed Monitoring Body, the NIAMS Executive Secretary will conduct a conflict of interest check on each member prior to beginning their service and on an annual basis thereafter. For studies with an Internally-appointed Monitoring Body (i.e., PI-appointed), the study team should provide the name, affiliation, and curriculum vitae (if available) of the proposed Monitoring Body member(s) to the NIAMS Executive Secretary for a conflict of interest check to be conducted. Once the conflict of interest check is complete, this section should be updated to indicate that the NIAMS did not identify any conflicts of interest for the Monitoring Body member(s). {Begin sample text} Monitoring body members should have no direct involvement with the study investigators or intervention. Each member will sign a Conflict of Interest Statement which includes current affiliations, if any, with any steering committees or advisory councils associated with the study, pharmaceutical and biotechnology companies (e.g., stockholder, consultant), and any other relationship that could be perceived as a conflict of interest related to the study and/or associated with commercial or non-commercial interests pertinent to study objectives. {End sample text} 5.5 Protection of ConfidentialityThis section describes how confidentiality of data presented to the Monitoring Body will be protected. {Begin sample text} Only masked data will be presented during the open sessions of the Monitoring Body meetings. All data, whether in a report or discussed during a MB meeting, are confidential. Participant identities will be kept confidential unless safety concerns necessitate unmasking some or all data. {End sample text} 5.6 Monitoring Body ResponsibilitiesA charter provides a detailed list of the Monitoring Body’s responsibilities. Listed in the sample text below are the responsibilities for a NIAMS-appointed Monitoring Body. Please ensure that all of the items are applicable for this study. For studies with an Internally-appointed Monitoring Body, the study team should ensure that a detailed list of the Monitoring Body’s responsibilities are provided in this section. {Begin sample text} The following are the responsibilities of the NIAMS-appointed DSMB: {End sample text} 6.0 Data Management, Quality Control, and Quality AssuranceThis section describes how the site will collect, document, and review the data. Who will be responsible for data entry and ensure they are accurate and complete? Which database will be used? Does it have audit tracking capabilities? What is the data query process and frequencies? Are there any planned mitigation strategies in the event of non-compliance? What is the process for locking the final study datasets? Are there any procedures on data access and sharing as appropriate? Is there a description of security measures in place? (If you have a separate Clinical Monitoring and Data Management Plan, please reference it and utilize that information to help populate this section). Each study should have standard operating procedures (SOPs) and/or a quality management plan that describe the following (if this is a multi-site study, each site should have SOPs and a plan): What is needed for an information security policy to remain viable?To be effective, an information security policy should: Cover end-to-end security processes across the organization. Be enforceable and practical. Be regularly updated in response to business needs and evolving threats.
What type of policy addresses specific areas of technology requires frequent updates and contains a statement on the organization's position on a specific issue?Issue-Specific Security Policy, ISSP, addresses specific technology, requires updates frequently, and contains a statement on the organization's position on specific issues.
What should an effective ISSP accomplish?An effective ISSP: Articulates the organization's expectations about how the technology-based system in question should be used. Documents how the technology-based system is controlled and identifies the processes and authorities that provide this control.
Which type of planning ensures that critical business functions continue if a catastrophic incident or disaster occurs?A disaster recovery plan (DRP) is a documented, structured approach that describes how an organization can quickly resume work after an unplanned incident. A DRP is an essential part of a business continuity plan (BCP).
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