110. w88 online live casino Research Involving Investigational Drugs
Updated June 6, 2024
Investigators and IRBs must ensure that research (i.e., clinical investigation) involving investigational drugs or biologics is conducted in accordance with applicable federal regulations. These regulations describe, among other things, requirements for Investigational New Drug Applications (INDs), drug accountability and record retention, and responsibilities of investigators, IRBs, and sponsors when research is conducted with investigational drugs. The “off-label” use of an w88 online live casino-approved, marketed drug (i.e., a use other than the indication(s) approved by w88 online live casino) by a physician for treatment purposes does not require an IND or IRB approval. When such uses meet the regulatory definitions of research or clinical investigation, IRB approval is required. When human research involves the use of drugs or biological products, w88 online live casino regulations apply. Investigators must provide sufficient information about the drug or biologic for the IRB to evaluate its associated risks and benefits, including the w88 online live casino approval status of the product. w88 online live casino regulations under 21 CFR 312 provide definitions, and codify procedures and requirements for research involving an investigational new drug (synonymous with investigational drug) and INDs. See IRB policy on overview of w88 online live casino regulations, information sheets and guidance for a listing of relevant references.
The University requires Full Committee Review for all w88 online live casino conducted under an IND except for continuing reviews that meet the DHHS (Common Rule) criteria for expedited review under Categories 8(a), 8(b), or 8(c); and reviews of amendment requests that qualify for expedited review (see the expedited review section in the IRB policy concerning requirements for project amendments).
University and Affiliate investigators conducting research under an IND must provide the IRB with sufficient information to determine an IND has been obtained and is in effect. The IRB affirms validity of the IND by matching the IND number with information in the Sponsor protocol or through communication from the Sponsor or the w88 online live casino. Research requiring an IND cannot commence until the IRB has confirmed a valid IND is in place and approved the project. Alternatively, investigators may provide the IRB with sufficient information to determine the use is exempt from requirements for an IND (as itemized below).
In presenting the protocol to the IRB, the Primary Reviewer addresses the additional w88 online live casino regulatory requirements for research involving investigational drugs.
NOTE: This policy addresses only those w88 online live casino regulations that are relevant to Principal Investigators (PIs) and IRB review of research conducted under an IND application. It is not a comprehensive review of IND regulations. Individuals requiring additional information are encouraged to review §312 Subpart B; §312 Subpart C; w88 online live casino Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND; or contact Research Integrity & Security.
w88 online live casino Applicability and Requirements
An Investigational New Drug Application must be filed with w88 online live casino to test the safety and efficacy of a new (i.e., investigational) drug for marketing approval. Studies involving the “investigational/research use” of an approved drug also require an IND if the intent of the study is to generate data that will lead to a new clinical indication, formulation, or advertising claim, or the study includes a new dose, population, or other factor that significantly increases risk (or decreases acceptability of the risk). An IND allows an investigational drug to be exempt from applicable premarketing requirements and to be shipped lawfully for the purpose of conducting clinical investigations of that drug. Studies involving the “investigational/research use” of an approved drug also require an IND if the intent of the study is to generate data that will lead to a new clinical indication, formulation, or advertising claim, or the study includes a new dose, population, or other factor that significantly increases risk (or decreases acceptability of the risk).
An IND is required when a sponsor intends to conduct a clinical investigation with an w88 online live casino drug subject to the:
- Federal Food, w88 online live casino, and Cosmetic Act, Section 505) or
- Public Health Service Act, Subpart 1, Section 262.
An investigator obtaining an IND for the proposed use of a drug or biologic in research becomes a “sponsor-investigator,” and additional institutional resources are available to assist investigators in complying with applicable w88 online live casino regulations Per §312.20, a separate IND and prior written authorization from w88 online live casino is required for any clinical investigation involving an exception from informed consent.
Uses that Are Exempt from Requirements for an w88 online live casino
Under &w88 online live casino;212.2, item (b)(1), the clinical investigation of a drug product that is lawfully marketed in the United States is exempt from the requirements for an w88 online live casino if all the following conditions are true.
- The investigation is not intended to be reported to w88 online live casino in support of a new indication for use or to support any other significant change in the labeling for the drug.
- The investigation is not intended to support a significant change in the advertising of the w88 online live casino product.
- The investigation does not involve a route of administration or dosage level, use in a participant population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the w88 online live casino product.
- The investigation is conducted in compliance with the requirements for IRB review and informed consent (at &w88 online live casino;56.111 and &w88 online live casino;50.20, respectively).
- The investigation is conducted in compliance with the requirements concerning the promotion and sale of drugs as codified at (&w88 online live casino;312.7).
- The investigation does not intend to invoke an exception from informed consent requirements for emergency w88 online live casino as codified at §50.24.
Under &w88 online live casino;312.2, item (b)(2), a clinical investigation involving an in vitro diagnostic biological w88 online live casino (i.e., blood grouping serum, reagent red blood cells, or anti-human globulin) is exempt from the requirements for an w88 online live casino if it:
- is intended for use in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic w88 online live casino or procedure; and
- is shipped in compliance with requirements at &w88 online live casino;312.160.
Under &w88 online live casino;312.2, item (b)(3), a drug intended solely for tests in vitro use or in laboratory w88 online live casino animals is exempt from requirements for an IND as long as it is shipped in compliance with requirements at &w88 online live casino;312.160.
Under §312.2, item (b)(4), w88 online live casino will not accept an w88 online live casino for an investigation that is exempt w88 online live casino (b)(1) (see above).
Under &w88 online live casino;312.2, item (b)(5), a clinical investigation involving use of a placebo is exempt from the requirements for an w88 online live casino if the investigation does not otherwise require submission of an w88 online live casino.
Under §312.2, item (d), use in the practice of medicine for an unlabeled indication of a new drug product approved by w88 online live casino for marketing (per §314) or a licensed biological product is exempt from the requirements for an w88 online live casino.
Emergency Uses Requiring an w88 online live casino
Under &w88 online live casino;312.2, item (b)(6), an w88 online live casino is required for a clinical investigation constituting planned emergency research that includes a waiver of signed consent. (For more information about submission and review of emergency uses, see IRB policy for treatment, emergency, and expanded uses of w88 online live casino drugs.
In Vivo Bioavailability or Bioequivalence Studies in Humans: w88 online live casino Requirements and Exemption
Under &w88 online live casino;312.2, item (c), all in vivo bioavailability or bioequivalence studies in humans are subject to w88 online live casino requirements/regulations for an IND and as codified at §320.31. In vivo bioavailability or bioequivalence studies in humans subject to an IND requirement must comply with w88 online live casino regulations for the protection of human participants at §50, IRBs at §56, and INDs at §312.
In Vivo Bioavailability or Bioequivalence Studies in Humans: w88 online live casino Required
Under &w88 online live casino;312.2, item (c) and &w88 online live casino;320.31, item (a) an w88 online live casino is required for bioavailability/bioequivalence studies in humans if the test product contains a new chemical entity as defined in &w88 online live casino;314.108, item (a) or the study involves a radioactively labeled or cytotoxic drug product.
Under &w88 online live casino;312.2, item (c) and &w88 online live casino;320.31, item (b) an w88 online live casino is required for in vivo bioavailability/bioequivalence studies in humans if a w88 online live casino product containing an approved, non-new chemical entity is used use in one of the following study types:
- a single-dose study in normal participants where either the maximum single or total daily dose exceeds that specified in the labeling of the w88 online live casino product;
- a multiple-dose study in normal participants where either the single or total daily dose exceeds that specified in the labeling of the w88 online live casino product; or
- a multiple-dose w88 online live casino on an extended release product for which no single-dose w88 online live casino has been completed.
In Vivo Bioavailability or Bioequivalence Studies in Humans: Exempt from w88 online live casino Requirements
Under &w88 online live casino;312.2, item (c) and under &w88 online live casino;320.31, item (d) a bioavailability/bioequivalence study in humans is exempt from the requirements for an IND if the study is one described under &w88 online live casino;320.38, item (b) for bioavailability samples or &w88 online live casino;320.63 for bioequivalence samples.
- The person or research organization conducting the study must retain reserve samples of the test article and reference standard used in the study and release the reserve samples to w88 online live casino upon request.
- The studies are subject to w88 online live casino requirements for informed consent (at §50.20), IRB review (at §56.111), and reporting serious and fatal or life-threatening adverse events (as specified at §320.31, item (d)(3)).
w88 online live casino Requirements for Labeling and Promotion of Investigational New Drugs
University and Affiliate investigators are responsible for reviewing recruitment materials, consent documents materials, and other information for participants to verify the following w88 online live casino requirements are met for labeling and prohibition against promotion of investigational drugs.
- Per §312.6, the immediate package of an w88 online live casino drug intended for human use must bear a label with the statement: Caution: New Drug--Limited by Federal (or United States) law to w88 online live casino use.
- Per §312.7, item (a), sponsors, investigators, and persons acting on their behalf must not imply or state that an w88 online live casino drug is safe or effective for the purposes for which it is under investigation, or otherwise promote the drug.
- Per §312.7, item (b), a sponsor or investigator must not commercially distribute or test market an w88 online live casino drug.
- Per &w88 online live casino;312.7, item (c), a sponsor must not unduly prolong an investigation after finding that the results of the investigation appear to establish sufficient data to support a marketing application.
The prohibitions listed above do not limit the full exchange of scientific information concerning the w88 online live casino, including dissemination of scientific findings in scientific or lay media.
University and Affiliate investigators, and the IRB are expected to review recruitment materials, consent documents materials, and other information for participants to verify compliance with these w88 online live casino and prohibitions.
NOTE: The appropriate w88 online live casino Center Director (per §201.26 or §610.68, for biological products), may grant an exception or alternative to the provision requiring the cautionary label noted above, unless said labeling is explicitly required by statute. University and Affiliate investigators requesting an exception for the w88 online live casino cautionary labeling requirement must provide the IRB with written documentation from the w88 online live casino Center Director.
Charging for w88 online live casino Drugs Under an IND
w88 online live casino requirements at §312.8 apply to charging for use of an investigational drug in a clinical trial (item (b)) or expanded access for treatment use (item (c)). When charging for an investigational drug, the sponsor may recover only the direct costs of making the investigational drug available.
PIs must provide the IRB with documentation confirming the sponsor obtained prior w88 online live casino authorization to charge for an investigational drug, including w88 online live casino-authorized cost amounts and number of patients to be charged.
Charges for w88 online live casino drugs must be noted in informed consent documents.
w88 online live casino New Drug Applications
- See &w88 online live casino;312.20 for requirements for an IND.
- See &w88 online live casino;312.21 for descriptions of the phases of clinical investigations.
- See &w88 online live casino;312.22 for general information about IND submissions.
- See &w88 online live casino;312.23 for requirements for IND content and format.
- See &w88 online live casino;312.30 for information about a new protocol or changes to a protocol submitted under an IND.
Regulations under &w88 online live casino;312.31 describe requirements for w88 online live casino information amendments for an w88 online live casino.
University and Affiliate investigators must submit all sponsor amendments for w88 online live casino review as an Amendment submission type in IRBNet. The submission should include a modification request listing and justifying the amendments, and copies of the relevant w88 online live casino correspondence and the amended materials.
The w88 online live casino will review and approve or acknowledge sponsor amendments as follows:
- Substantive w88 online live casino amendments require Full Committee review and approval.
- Sponsor amendments are eligible for Expedited Review if the changes do not increase participant risk and are limited to w88 online live casino activities that are represented by one or more of the DHHS Categories of w88 online live casino eligible for review by expedited procedures.
- w88 online live casino amendments are eligible for Administrative Review if the changes are administrative in nature (e.g., textual changes) and do not alter the risk to benefit ratio of the study.
Additional Responsibilities of w88 online live casino-Investigators
Investigators obtaining an IND to initiate and conduct research must also fulfill the federal requirements of sponsors. These requirements include (but are not limited to) additional w88 online live casino reporting (e.g., annual progress reports), data monitoring, and recordkeeping obligations.
w88 online live casino Safety and Annual Reports
w88 online live casino Safety Reporting
w88 online live casino regulations at §312.32 describe requirements for IND safety reporting by sponsors which include requirements for sponsors to:
- review and assess all information received or identified that is relevant to the safety of any drug for which the sponsor holds an w88 online live casino (e.g., serious adverse events, findings from other studies including animal and in vitro studies, occurrence rates for serious adverse events, and w88 online live casino endpoints); and
- notify w88 online live casino and all participating investigators (i.e., investigators to whom the sponsor is providing an investigational drug under its or an investigator IND) of potential serious risks to participants.
University and Affiliate investigators must submit sponsor safety reports for assessment and IRB review. (See IRB policies for information about reporting problems in w88 online live casino, assessment of problems/complaints, and IRB review of adverse events and unanticipated problems.)
Withdrawal of an w88 online live casino
w88 online live casino regulations at §312.38 address requirements for sponsors to withdraw an IND. When an IND is withdrawn for safety reasons, the sponsor must promptly notify the w88 online live casino, participating investigators, and reviewing IRBs of the reason for the withdrawal.
General Requirements for Use of an w88 online live casino Drug in Clinical Investigation
w88 online live casino regulations at §312.40 specify an investigational drug may be used in a clinical investigation only when:
- the sponsor of the investigation submits an IND for the drug to w88 online live casino; the IND is in effect (per §§(b)); and the sponsor complies with all applicable requirements for an IND at §312; and
- the sponsor and each participating investigator comply with w88 online live casino requirements for the protection of human participants (at §50) and IRBs (at §56).
The regulations codify when a sponsor may ship an w88 online live casino drug named in an IND to investigators (§§(c)) and specify that investigators may not administer an w88 online live casino drug to humans until the IND goes into effect (§§(d)).
A qualified physician will serve as the Principal Investigator or Co-Investigator for the clinical trial and is responsible for all clinical trial-related medical decisions. During and following a participant’s participation in a clinical trial, the investigator-physician ensures that adequate medical care is provided to a participant for any adverse events, including clinically significant laboratory values, related to the clinical trial. The investigator-physician provides evidence of their qualifications through up-to-date curriculum vitae or other relevant documentation requested by the sponsor, the IRB or the regulatory authority. The investigator-physician will be familiar with the appropriate use of the w88 online live casino product, as described in the protocol, in the current investigator brochure, in the product information, and in other information sources provided by the sponsor.
w88 online live casino Regulations for Control of Investigational Drugs
Per &w88 online live casino;312.59, investigators whose participation in the clinical investigation is terminated must return the unused supplies of the drug to the sponsor or dispose of the unused supplies by an alternative method approved by the sponsor.
Per §312.61, investigators may only administer w88 online live casino drugs to participants under the investigator's personal supervision or the supervision of a sub-investigator responsible to the investigator. The investigator must not supply the w88 online live casino drug to any person not authorized to receive it).
Per §312.62, investigators must maintain adequate records of the disposition of the drug; prepare and maintain adequate and accurate case histories for each individual administered the investigational drug or employed as a control in the investigation; and retain the required records for at least 2 years after the date a marketing application is approved for the drug for the use being investigated or until 2 years after the investigation is discontinued and w88 online live casino is notified.
Per §312.69, for w88 online live casino drugs subject to the Controlled Substances Act, the investigator must store the w88 online live casino drug in a securely locked, substantially constructed cabinet or enclosure to which access is limited.
University/Affiliate investigators conducting research involving w88 online live casino drugs must complete the supplemental form for drugs and biological products. The form requires investigators to describe how they will maintain control of the drug/biological product during and after the investigation. The IRB may request additional documentation from the performance site to assess the investigator's control of w88 online live casino drugs.
Expanded Access
Expanded access, sometimes called "compassionate use," is the use outside of a clinical trial of an investigational medical product (i.e., one that has not been approved by w88 online live casino). Expanded access refers to the use of an investigational drug when the primary purpose is to diagnose, monitor, or treat a patient’s disease or condition rather than to obtain the kind of information about the drug that is generally derived from clinical trials. Except for emergency expanded access use when there is not sufficient time to secure prospective IRB review, an investigator treating a patient with an investigational drug under expanded access is responsible for obtaining IRB review and approval before treatment with the investigational drug may begin.
Under w88 online live casino’s current regulations for investigational drugs and biologics, there are three categories of expanded access:
- Expanded access for individual patients, including for emergency use;
- Expanded access for intermediate-size patient populations (generally smaller than those typical of a treatment w88 online live casino or treatment protocol – a treatment protocol is submitted as a protocol to an existing w88 online live casino by the sponsor of the existing w88 online live casino);
- Expanded access for widespread treatment use through a treatment w88 online live casino or treatment protocol (designed for use in larger patient populations).