Who is sponsor in clinical research

This is particularly important when making changes to the computerized systems, such as software upgrades or migration of data. Essential Documents for the Conduct of a Clinical Trial. These documents should be retained for a longer period however if required by the applicable regulatory requirement s or if needed by the sponsor.

Each investigator should be qualified by training and experience and should have adequate resources see 4. Prior to initiating a trial, the sponsor should define, establish, and allocate all trial-related duties and functions. Investigator's Brochure.

In addition, the labelling should comply with applicable regulatory requirement s. The sponsor should inform all involved parties e. The procedures should address adequate and safe receipt, handling, storage, dispensing, retrieval of unused product from subjects, and return of unused investigational product s to the sponsor or alternative disposition if authorized by the sponsor and in compliance with the applicable regulatory requirement s.

To the extent stability permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement s , whichever represents the longer retention period. The sponsor should determine the appropriate extent and nature of monitoring. The determination of the extent and nature of monitoring should be based on considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the trial. Statistically controlled sampling may be an acceptable method for selecting the data to be verified.

The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials.

The flexibility in the extent and nature of monitoring described in this section is intended to permit varied approaches that improve the effectiveness and efficiency of monitoring. The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy e. On-site monitoring is performed at the sites at which the clinical trial is being conducted.

Centralized monitoring is a remote evaluation of accumulating data, performed in a timely manner, supported by appropriately qualified and trained persons e. Review, that may include statistical analyses, of accumulating data from centralized monitoring can be used to:. Acting as the main line of communication between the sponsor and the investigator.

Verifying that the investigator has adequate qualifications and resources see 4. Verifying, for the investigational product s :. That storage times and conditions are acceptable, and that supplies are sufficient throughout the trial.

That the investigational product s are supplied only to subjects who are eligible to receive it and at the protocol specified dose s. That subjects are provided with necessary instruction on properly using, handling, storing, and returning the investigational product s.

That the receipt, use, and return of the investigational product s at the trial sites are controlled and documented adequately. That the disposition of unused investigational product s at the trial sites complies with applicable regulatory requirement s and is in accordance with the sponsor.

Verifying that the investigator follows the approved protocol and all approved amendment s , if any. Per the RevisedCommonRule , for non-exempt research or exempt research that requires limited EC review reviewed by an EC not operated by the institution doing the research, the institution and the EC must document the institution's reliance on the EC for research oversight and the responsibilities that each entity will undertake to ensure compliance with the RevisedCommonRule.

Compliance can be achieved in a variety of ways, such as a written agreement between the institution and a specific EC, through the research protocol, or by implementing an institution-wide policy directive that allocates responsibilities between the institution and all ECs not operated by the institution. As delineated in 21CFR56 , the CommonRule , and the RevisedCommonRule , the EC must also pay special attention to reviewing informed consent and to protecting the welfare of certain classes of participants deemed to be vulnerable.

The EC is also responsible for ensuring a competent review of the research protocol, evaluating the possible risks and expected benefits to participants, and verifying the adequacy of confidentiality safeguards. An EC may review studies that are not performed on-site. In the event of multicenter clinical studies, also known as cooperative research studies, which must comply with the RevisedCommonRule , it is required that all federally-funded or sponsored institutions located in the US and engaged in multicenter research use a single EC to review that study for the portion of the study conducted in the US, known as the EC policy.

This policy will streamline the EC review process and eliminate duplicative reviews. The exceptions to this requirement include: when multicenter review is required by law including tribal law or for research where any federal department or agency supporting or conducting the research determines that the use of a single EC is not appropriate. For more information on multicenter research, see G-CoopRes. Although the regulations do not specify an expiration for EC approval, 21CFR56 and the G-IRBContRev state that any clinical investigation must not be initiated unless the reviewed and approved study remains subject to continuing review at intervals appropriate to the degree of risk, but not less than once a year.

Per the CommonRule , the EC must conduct reviews at intervals appropriate to the degree of risk, but not less than once per year. The RevisedCommonRule provides the following exceptions:. Users should refer to Section of the RevisedCommonRule for detailed information on research categories specifically exempt from EC review, or exempt activities requiring limited EC review or broad consent. Per USA , for secondary research that does not qualify for an exemption under the RevisedCommonRule , the applicant must either apply for a waiver of the informed consent requirement from the EC, obtain study-specific informed consent, or obtain broad consent.

Further, the RevisedCommonRule modifies what constitutes research to specifically exclude the following types of research:. Many institutional ethics committees ECs referred to as institutional review boards IRBs in the United States US charge fees to review research proposals submitted by industry-sponsored research or other for-profit entities. However, this varies widely by institution.

Per the RevisedCommonRule , which took effect January 21, , non-exempt research or exempt research that requires limited EC review reviewed by an EC not operated by the institution doing the research, the institution and the EC must document the institution's reliance on the EC for research oversight and the responsibilities that each entity will undertake to ensure compliance with the RevisedCommonRule. Non-US ECs may register voluntarily.

FDA EC registration must be renewed every three 3 years. EC registration becomes effective after review and acceptance by HHS. If an EC lacks the ability to register electronically, it must send its registration information in writing to:.

An individual authorized to act on behalf of the institution operating the EC must submit the registration information. Neither EC competence nor expertise is assessed during the registration review process by either agency. Per 21CFR and the G-IND-Determination , whether an IND is required to conduct an investigation of a drug to be marketed this includes biological products under the FDCAct primarily depends on the intent of the investigation, and, the degree of risk associated with the use of the drug in the investigation.

See the Regulatory Authority topic, Scope of Assessment subtopic for more information. Beltsville, MD Therapeutic Biological Products: U. Based on information provided in 21CFR , for paper IND submissions, the sponsor must submit an original and two 2 copies, including the original submission and all amendments and reports.

Noncommercial INDs are exempt from this submission requirement. See USA-8 for information on how to create an account. As indicated in the G-eCTDspecs , physical media should comply with the following requirements:.

See the G-eCTDspecs for additional physical media information. The IND must be submitted in English. The sponsor must also submit a copy of each original literature publication for which an English translation is submitted. According to G-PedStudyPlans , a sponsor who is planning to submit a marketing application or supplement to an application for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration is required to submit an initial pediatric study plan iPSP , if required by the Pediatric Research Equity Act PREA.

An exception to this is if the drug is for an indication granted an orphan designation. For detailed application requirements, see 21CFR Furthermore, for information on the appropriate use of adaptive designs for clinical trials and additional information to provide the FDA to support its review, see G-AdaptiveTrials.

Each EC has its own application form and clearance requirements, which can differ significantly regarding the number of copies supplied and application format requirements. Per the RevisedCommonRule , which took effect January 21, , where limited EC review applies, the EC does not need to make the determinations outlined above.

Clinical studies shall not be initiated until 30 days after the date of receipt of the IND application by the FDA unless earlier notification is received from the FDA that studies may begin. Each EC maintains its own procedures and processes for review. Consequently, there is no stated regulatory requirement for a standard timeline of review and approval of the clinical trial. As per 21CFR , once an IND has been submitted and following the day review period, the sponsor is permitted to import an investigational product IP.

This policy requires all NIH-funded awardees and investigators conducting clinical trials, funded in whole or in part by the NIH, regardless of study phase, type of intervention, or whether they are subject to the regulation, to ensure that they register and submit trial results to ClinicalTrials. See also the G-DataBankPnlty for clarification on the types of civil money penalties that may be issued for failing to register a clinical trial.

In this case, as stated in 21CFR50 , the FDA requires the establishment of an independent data monitoring committee to exercise oversight of the clinical investigation.

The US-ICH-GCPs recommends establishing a DSMB to assess the progress of a clinical trial, including the safety data and the critical efficacy endpoints at intervals, and to recommend to the sponsor whether to continue, modify, or stop a trial. DSMBs are also required for multi-site clinical trials with interventions that involve potential participant risk.

The sponsor is required to submit a follow-up safety report to provide additional information obtained pertaining to a previously submitted safety report. This report should be submitted without delay, as soon as the information is available, but no later than 15 calendar days after the sponsor initially receives the information.

In each safety report, the sponsor must identify all safety reports previously submitted to the FDA concerning a similar SAR, and must analyze the significance of the SAR in light of previous, similar reports, or any other relevant information.

As part of the clinical trial results information submitted to ClinicalTrials. The tables should consist of the following summarized data:. This information must be submitted no later than one 1 year after the primary completion date of the clinical trial.

Submission of trial results may be delayed as long as two 2 years if the sponsor or PI submits a certification to ClinicalTrials. Additionally, as indicated in the CommonRule and the RevisedCommonRule , for HHS funded or sponsored human subjects research, the institutional EC shall ensure that, when appropriate, the research plan makes adequate provision for monitoring the data collected during the study to ensure participant safety. DSMBs are specifically required for NIH-funded, multi-site clinical trials with interventions that involve potential participant risk.

As specified in 21CFR , the investigator must furnish all reports to the sponsor who is responsible for collecting and evaluating the results obtained. The report must contain the following information for each study:. There is no specific timeframe stipulated for when the report should be completed. See 42CFR11 for more detailed requirements. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.

The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. The term does not include any person other than an individual.

Any trial-related responsibilities transferred to and assumed by a CRO should be specified in writing, and those obligations not covered by the written description shall be deemed not to have been transferred. Further, a CRO that assumes any sponsor obligations must comply with the specific regulations delineated in 21CFR and shall be subject to the same regulatory action as the sponsor for failure to comply with any obligation assumed under these regulations.

As indicated in 21CFR , a sponsor may be either domestic or foreign. Per 21CFR , to complete the IND application package, the sponsor must provide the following information in paper format or electronically:. The G-CTDiversity also provides recommendations to sponsors for increasing enrollment of underrepresented populations in their clinical trials.

The United States US regulations do not require compensation for trial participants either for participation in a trial or in the event of trial-related injuries or death.

The sponsor must also inform participants who suffer any trial-related injuries of any available medical treatments, what they consist of, and where further information can be obtained. Payment amounts and schedules should be presented to the ethics committee EC institutional review board IRB in the US at the time of the initial review. The EC should ensure the payment amount and the proposed method and timing of disbursement are not coercive or present undue influence, and are also included in the informed consent document.

Payment to participants who withdraw may be made at the time that they would have completed the study. Further, FDA does not consider reimbursement for travel expenses to and from the clinical trial site and associated costs such as airfare, parking, and lodging to raise issues regarding undue influence. Per the US-ICH-GCPs , the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results.

The quality management system should use a risk-based approach that includes:. QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. A written agreement must be signed by both the sponsor and the investigator or any other parties involved with the clinical trial, verifying that all parties agree to the trial protocol, the monitoring and auditing practices, the SOPs, and their respective duties.

In addition, the sponsor must maintain SOPs that cover system setup, installation, and use. The SOPs should describe system validation and functionality testing, data collection and handling, system maintenance, system security measures, change control, data backup, recovery, contingency planning, and decommissioning. With respect to the use of these computerized systems, the responsibilities of the sponsor, investigator, and other parties should be clear, and the users should receive relevant training.

See G-eHealthRecords for guidance related to the use of electronic health records in clinical research. Additionally, per 21CFR , the sponsor must upon request from the FDA, permit an officer or employee to access, copy, and verify any records and reports relating to the clinical investigation. Upon written request by the FDA, the sponsor must also submit the records or reports or copies of them to the agency.

The storage system used during the trial and for archiving irrespective of the type of media used should allow for document identification, version history, search, and retrieval. The sponsor should ensure that the investigator has control of and continuous access to the data reported to the sponsor. The sponsor should appoint auditors to review the clinical trial. The sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical trials. The extent and nature of monitoring is flexible and permits varied approaches that improve effectiveness and efficiency.

The sponsor may choose on-site monitoring, a combination of on-site and centralized monitoring, or, where justified, centralized monitoring. The sponsor should document the rationale for the chosen monitoring strategy e. The sponsor must also notify the FDA, all institutional ethics committees ECs institutional review boards IRBs in the United States , and all investigators who have participated in the study about the termination.

According to the US-ICH-GCPs , if it is discovered that noncompliance significantly affects or has the potential to significantly affect participant protection or reliability of trial results, the sponsor should perform a root cause analysis and implement appropriate corrective and preventive actions. The sponsor determines the location s of the trials, which are usually conducted at universities, medical centers, clinics, hospitals, and other Federally or industry-funded research sites.

FDA works to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks.

Signing it indicates that you understand that the trial is research and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.

Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial. Also, discuss the trial with your health care provider to determine whether or not the trial is a good option based on your current treatment.

Be sure you understand:. Marketing application means an application for a new drug submitted under section b of the act or a biologics license application for a biological product submitted under the Public Health Service Act. Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization.

The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.

Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.