Free Standard Operating Procedure Template Word 2010

The NIMH Analytic Analysis Toolbox serves as an advice athenaeum for NIMH agents and the analytic analysis community, decidedly those accepting NIMH funding. The Toolbox contains assets such as NIH and NIMH action and advice documents, templates, sample forms, links to added resources, and added abstracts to abetment analytic lath in the development and conduct of high-quality analytic analysis studies.

Use of these templates and forms is optional; the assets can be acclimated as-is or customized to serve abstraction aggregation needs. In cases area institutions accommodate analysis teams with institution-specific templates and forms for analytic analysis documentation, NIMH expects advisers to chase their institutional behavior for certificate use. Nevertheless, the abstracts on this folio can be consulted to assure that abstraction teams are affair NIMH expectations.

NIMH encourages lath to accede appliance one of the agreement templates beneath back developing a analytic analysis protocol. In cases area an institutional analysis lath (IRB) has a recommended or adapted agreement template, reviewing the abstracts included beneath is still suggested as there may be sections that a abstraction aggregation may opt to accommodate in an accomplishment to advance a absolute analysis protocol.

NIH has developed a Analytic e-Protocol Autograph Tool to abutment the collaborative autograph and analysis of protocols for behavioral and amusing sciences analysis involving humans, and of appearance 2 and 3 analytic balloon protocols that crave a Food and Biologic Administering (FDA) Investigational New Biologic (IND) or Investigational Accessory Exemption (IDE) Application.

This analytic balloon agreement arrangement is a adapted architecture for Appearance 2 and 3 analytic trials adjourned by NIH that are actuality conducted beneath a FDA IND or IDE Application.

Investigators for such trials are encouraged to use this arrangement back developing protocols for NIH-funded analytic trial(s). This arrangement may additionally be advantageous to others developing appearance 2 and 3 IND/IDE analytic trials.

This analytic balloon agreement arrangement is a adapted architecture for behavioral or psychosocial analytic trials adjourned by NIH. Lath for such studies are encouraged to use this arrangement back developing protocols for NIH-funded analytic trial(s). This arrangement may additionally be advantageous to others developing behavioral of psychosocial analysis studies.

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This arrangement provides a recommended anatomy for developing constant instructions on abstraction action accomplishing and abstracts accumulating beyond actor and analytic armpit activities. It capacity the study’s organization, operations, procedures, abstracts management, and affection control.

This arrangement provides a recommended anatomy for a plan to conduct centralized or absolute analysis of Acceptable Analytic Practices (GCP), animal accountable safety, and abstracts candor throughout the lifecycle of a study.

Informed Accord Materials

Often abstraction teams will be provided with abreast accord anatomy templates and advice on requirements for the abreast accord action by their institutions. Beneath is added advice and abstracts to abutment a absolute abreast accord process.

The NIMH Abstracts Archive (NDA) receives de-identified animal capacity abstracts calm from hundreds of analysis projects beyond abounding authentic domains, and makes these abstracts accessible to accredit collaborative science. This NDA sample abreast accord accent for abstracts administering can be acclimatized back appliance one of the NDA platforms.

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Regulatory Certificate Checklists by Abstraction TypeThe afterward checklists are advised to advice the investigator association analyze a set of amount abstracts to be organized aural a audible abstraction specific folder, either electronically, adamantine copy, or a admixture of both formats. NIMH encourages abstraction teams to verify what added documents, or another formats of the abstracts in the checklists, their academy and IRB require.

Study teams can use this account to abridge capital abstracts for the conduct of a NIMH-funded abstraction that does not accommodated the NIH analogue of a analytic balloon and is analysis on animal subjects.

Study teams can use this account to abridge capital abstracts for the conduct of a NIMH-funded NIH authentic analytic balloon that does not absorb an investigational biologic or device.

Study teams can use this account to abridge capital abstracts for the conduct of a NIMH-funded NIH authentic analytic balloon with an investigational biologic or accessory that is not beneath a FDA IND or IDE.

Study teams can use this account to abridge capital abstracts for the conduct of a NIMH-funded NIH authentic analytic balloon or non-clinical balloon with an investigational biologic or accessory beneath a FDA IND or IDE.

Necessary Abstracts for Reportable Events

This certificate provides a log arrangement for documenting reportable events. The types of contest that crave advertisement may alter by institution, IRB, sponsor, state, and added factors.

This certificate provides a log arrangement for tracking all agreement deviations/violations beyond a study.

This certificate provides a log arrangement for tracking subject-specific agreement deviations/violations. If captured electronically, subject-specific aberration logs can be exported into a study-wide aberration log.

This certificate provides a log arrangement for tracking all adverse contest (AEs), including austere adverse contest (SAEs), beyond a study.

This certificate provides a log arrangement for tracking adverse contest (AEs), including austere adverse contest (SAEs), for anniversary subject. If captured electronically, subject-specific AE logs can be exported into an cyberbanking study-wide AE log.

Necessary Abstracts for Studies with Pharmacy/Investigational Product

This FDA anatomy should be active by the investigator above-mentioned to abstraction admission to accommodate assertive advice to the sponsor, and assure that he/she will accede with FDA regulations accompanying to the conduct of a analytic analysis of an investigational biologic or biologic.

This certificate provides a sample accepted operating procedures (SOP) arrangement to certificate how investigational artefact (IP) will be received, stored, monitored, labeled, dispensed, and destroyed.

This certificate provides a log arrangement for recording the circadian temperatures for investigational artefact (IP).

This certificate provides a log arrangement for capturing all investigational artefact (IP) dispensed to and alternate by participants for the continuance of the study.

This certificate provides a log arrangement for capturing all investigational artefact (IP) dispensed to an alone actor and alternate by that participant. This log is about placed in anniversary subject’s abstraction adhesive (study dark is maintained, if applicable).

Screening and Acceptance Logs and Materials

This certificate provides a log arrangement for all abeyant participants who accept completed antecedent screening procedures (i.e. buzz screens or internet screening surveys; typically, above-mentioned to signing accounting abreast consent). This log should abduction the cardinal of participants acceptable for an official screening visit, as able-bodied as the cardinal disqualified with the affidavit for awkwardness listed.

This certificate provides a log arrangement for chronologically documenting the participants who accept been enrolled in the study.

This certificate provides a sample account to adapt according to protocol-specific accommodation criteria. A able and appropriately-delegated abstraction aggregation affiliate should assurance and date to affirm accommodation already all belief accept been assessed. If belief are adjourned on altered appointment dates, this account should be reformatted to reflect which belief are adjourned on which appointment dates, and who is amenable for assessing them.

This certificate provides a sample anatomy arrangement for documenting the abreast accord process.

Additional Actor Tracking Logs and Materials

This certificate provides a log arrangement for recording anniversary participant’s medications throughout the study. This log is about advised at all accountable abstraction visits and is amid in anniversary participant’s abstraction binder.

This certificate provides a log arrangement for tracking the accumulating and accumulator of analysis samples.

Staff Training and Authoritative Tracking Logs and Materials

This certificate provides a log arrangement for documenting achievement of Acceptable Analytic Practice (GCP) training requirements. Note: all NIH-funded lath and agents who are complex in the conduct, oversight, or administering of analytic trials should be accomplished in Acceptable Analytic Practice (GCP), constant with attempt of the International Conference on Harmonisation (ICH) E6 (R2). Alone institutions may crave GCP training behindhand of allotment antecedent or analytic balloon status.

This certificate provides a log arrangement for documenting agents trainings for study-specific procedures (i.e., trainings for analytic account administration, abstraction agreement adherence, phlebotomy, outcomes measures, OSHA Bloodborne Pathogens, etc.).

This certificate can be acclimated to almanac all abstraction agents members’ cogent study-related duties, as delegated by the Principal Investigator (PI). Best studies opt to use a log format, such as the Appointment of Authority log, because it captures abstraction agents on one folio and includes amplitude to certificate the accession or abatement of specific abstraction tasks for alone agents members.

This certificate is about completed by the analytic armpit adviser to certificate dates and purpose of analytic armpit ecology visits.

This certificate provides a sample arrangement for breeding notes-to-file, which are accounting to accede a alterity or botheration with the study’s conduct, or for added authoritative purposes (such as to certificate area abstraction abstracts are stored).

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Even admitting it is the NIMH’s apprehension that grantees will accommodate able blank of their analytic research, NIMH Affairs Officials may crave added levels of on-site ecology conducted by NIMH staff. Analytic ecology helps ensure the rights and abundance of animal capacity are protected; the appear analytic analysis abstraction abstracts are accurate, complete, and verifiable; and the conduct of the abstraction is in acquiescence with the abstraction protocol, Acceptable Analytic Practice (GCP), and the regulations of applicative agencies.

The NIMH Analytic Analysis Education, Support, and Training (CREST) Affairs provides advancing educational and abstruse abutment from NIMH agents for analytic analysis action grants called for appointment and/or armpit visit(s). The CREST Affairs aims to ensure that the appear analytic analysis abstraction abstracts are accurate, complete, and verifiable, the conduct of the abstraction is in acquiescence with the abstraction protocol, Acceptable Analytic Practice (GCP) and the regulations of applicative agencies, and the rights and abundance of animal capacity are protected, in accordance with 45 CFR 46 (Protection of Animal Subjects) and, as applicable, 21 CFR allotment 50 (Protection of Animal Subjects).

To advance analytic analysis that is adjustable with GCP and animal accountable regulations, the CREST Affairs includes buzz conversations, email consultation, and/or armpit visit(s) from NIMH staff, as needed, to appraise and accommodate accounting acknowledgment and recommendations on planned or advancing analytic analysis protocols. Abstracts apropos to the conduct of the analytic research, such as accepted IRB accustomed protocols, abreast accord documents, antecedent documents, and biologic accountability records, as applicable, may be advised for acquiescence with applicative Federal regulations, and institutional and IRB policies.

Research action grants called for admittance in the CREST Affairs ability accommodate analytic analysis studies with “significantly-greater-than-minimal risk” to capacity (e.g., an action or invasive action with aerial abeyant for austere adverse events; see NIMH Risk-Based Ecology Guidance); a abstraction action beneath a FDA Investigational New Biologic or Investigational Accessory Exemption; or added studies articular by NIMH agents that may account from admittance in CREST. CREST is abstracted and audible from “for cause” audits of analytic research. Analysis grants may be included in CREST at any time during the abstraction lifecycle, although projects are about articular and called for the affairs at the admission of the grant.

This folio provides a description of the NIMH CREST Program’s purpose, action for inclusion, and operating procedures.

Site Visits

This arrangement provides a recommended anatomy for a CREST armpit appointment report, as able-bodied as a sample cast of authoritative belief that CREST monitors attending at while at armpit admission visits (SIVs), acting ecology visits (IMVs) and abutting out visits (COVs). It is to be acclimated as a starting point for advancing for a CREST armpit appointment or for autograph a armpit appointment report.

This certificate provides a sample armpit admission appointment calendar to be customized by the Principal Investigator (PI) and armpit adviser above-mentioned to the visit.

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This area provides resources, including action and advice abstracts accompanying to the conduct of animal accountable research. The assets included beneath represent those frequently of absorption to NIMH investigators, specifically: overviews of animal accountable research, abstracts and assurance monitoring, animal accountable risk, reportable events, and recruitment. There are abundant added NIH webpages adherent to animal capacity research; see Analysis Involving Animal Subjects, NIH Animal Capacity Behavior and Guidance, and New Animal Capacity and Analytic Balloon Advice Form.

The Office for Animal Analysis Protections (OHRP) has developed clear aids to advice adviser lath in chief if an action is analysis involving animal capacity that charge be advised by an IRB beneath the requirements of the U.S. Department of Bloom and Animal Services (HHS) regulations (45 CFR 46).

This NIMH webpage presents items which lath should pay accurate absorption to back proposing to use animal capacity in NIMH-funded studies.

This NIMH advice aims to analyze accident akin definitions and the NIMH’s ecology expectations to abate these risks. This advice will abetment abstraction teams in free the akin of abstracts and assurance ecology that should be accustomed for a abstraction based on the anticipation and consequence of advancing abuse and discomfort.

The policies, advice and affidavit in this area outline NIMH expectations for abstracts and assurance ecology of analytic trials. For animal accountable analysis that does not accommodated belief for NIH analytic balloon designation, lath still accept an advantage of including a abstracts and assurance ecology plan (DSMP; i.e., in studies that may accept cogent accident to participants). The antecedent links beneath administer to all NIMH-funded analytic trials, while the additional area provides affidavit for analytic trials beneath the blank of a NIMH-constituted abstracts and assurance ecology lath (DSMB).

All Analytic Trials

This NIMH action outlines NIH and NIMH expectations for abstracts and assurance ecology of analytic trials. This action additionally assures that the NIMH is notified by NIMH-funded advisers in a adapted address of all directives appearing from ecology activities.

This advice was created to aid lath developing a abstracts and assurance ecology plan (DSMP) to ensure the assurance of analysis participants and to assure the authority and candor of abstraction abstracts in analytic trials accurate by NIMH. This advice applies to abstracts and assurance ecology for all NIMH-supported analytic trials (including grants, accommodating agreements, and contracts).

This action establishes expectations for the ecology of NIMH-supported analytic trials by Absolute Assurance Monitors (ISMs) and/or absolute abstracts and assurance ecology boards (DSMBs) to assure the assurance of analysis participants, authoritative compliance, and abstracts integrity.

Trials Advised by a NIMH-Constituted DSMB

The abstracts beneath are for studies appointed for analysis by a NIMH-constituted DSMB. Abstraction teams developing abstracts for a study-constituted absolute DSMB may account from reviewing the abstracts address arrangement and the agreement alteration memo.

This letter provides an acclimatization to alive with the NIMH Analytic Trials Operations Branch which supports abstraction teams advertisement to the NIMH DSMB.

This arrangement may be acclimated back appointment a abstraction agreement or accord certificate alteration to the NIMH DSMB.

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This action is advised to abutment able and able appliance of participants into all NIMH extramural-funded analytic analysis studies proposing to accept 150 or added capacity per study, and all analytic trials, behindhand of size.

This action outlines NIMH expectations apropos the enactment of appliance affairs and milestones for all-embracing abstraction enrollment, and as appropriate, appliance affairs for females and males, associates of ancestral and indigenous boyhood groups, and children, as able-bodied as appliance reporting.

This NIMH FAQ certificate provides responses to several of the best accepted questions surrounding RMR.

These “points to consider” are meant to serve as a ability as lath plan a analytic analysis abstraction and a NIMH admission application. It additionally outlines accepted barriers that can appulse analytic appliance and retention.

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This web certificate is advised to abutment the development of NIMH analysis admission applications in suicide research, including those accompanying to analytic course, accident and detection, and interventions and implementation, as able-bodied as to abutment analysis conduct that is safe, ethical and feasible.

Based on the NIH Acceptable Analytic Practice (GCP) policy, all NIH-funded analytic lath and analytic balloon agents who are complex in the design, conduct, oversight, or administering of analytic trials are claim to be accomplished in GCP. Beneath are links to some GCP courses that accommodated NIH GCP training expectations.

The NIH Office of Behavioral and Amusing Sciences Analysis (OBSSR) offers a self-paced Acceptable Analytic Practice (GCP) training advance with nine video modules. Learners complete ability checks and contest throughout the course.

NIAID has created a self-paced Acceptable Analytic Practice (GCP) training advance that includes four modules. These modules brainwash the abecedarian on the history of animal accountable research, the authoritative framework, planning animal accountable research, and administering animal accountable research.

This NDAT advance includes 12 modules based on International Council for Harmonisation (ICH) Acceptable Analytic Practice (GCP) and the Code of Federal Regulations (CFR) for analytic analysis studies in the U.S. The advance is self-paced and takes about six hours to complete.

The afterward notices and links present NIMH expectations and accoutrement for abstracts sharing.

This apprehension establishes NIMH’s abstracts administering expectations, including the appeal to accommodate a abundant abstracts administering plan as allotment of admission applications.

This apprehension encourages lath in the brainy bloom analysis association to advance abstracts accumulating protocols appliance a accepted set of accoutrement and assets to facilitate sharing, comparing, and affiliation of abstracts from assorted sources.

The NIMH Abstracts Archive is an informatics belvedere for the administering of de-identified animal accountable abstracts from all analytic analysis adjourned by the NIMH.

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The afterward educational abstracts are provided to abutment the training of NIMH-funded analytic analysis lath and staff.

This training presentation defines Acceptable Analytic Practice (GCP) and describes its appliance in NIMH-funded research. Topics include: investigator responsibilities, training and qualifications, assets and staffing, appointment of responsibilities, abreast consent, affidavit and accumulator of data, appraisal and reporting, agreement adherence, biologic accountability, adverse events/unanticipated problems and noncompliance. Note that this presentation does not alter the Acceptable Analytic Practice (GCP) training adapted for NIH adjourned investigators.

This training presentation provides an overview of acceptable affidavit practices to chase throughout the continuance of NIMH-funded research. The presentation defines and gives examples of acceptable affidavit practices.

This training presentation provides an overview of the action of establishing and ensuring the affection of processes, data, and affidavit associated with analytic analysis activities. Affection Administering (QM) is authentic in accord to site-level documentation, processes, and activities. Accoutrement that are accessible to abutment site-level QM are additionally described.

This training presentation provides an overview of Analytic Monitoring, types of armpit ecology visits and what takes abode during these visits as able-bodied as an overview of aftereffect activities. The presentation accurately describes the NIMH Analytic Analysis Education Abutment and Training (CREST) Program, its goals, abstraction portfolio alternative process, and accepted procedures.

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