Indian clinical trial registration

CTRI also accepts registration of trials from other countries, provided the relevant ethics approval is in English. Following are some links that provide detailed information regarding the CTRI registration process:. Clinical Trials Toolkit — India. Clinical Trial Registration. As set forth in the CTRules and the G-ICMR , in all clinical trials, research participants selected from vulnerable populations must be provided additional protections to safeguard their health and welfare during the informed consent IC process.

The G-ICMR further describes vulnerable groups and individuals as those who may have an increased likelihood of incurring additional harm, as they may be relatively or absolutely incapable of protecting their own interests. See the G-ICMR for detailed safeguards that must be complied with when trials involving vulnerable populations are conducted.

Permission to conduct clinical trials in geriatric patients must comply with the requirements listed in the Informed Consent topic, Required Elements subtopic.

Sexual Minorities and Sex Workers. Per the G-ICMR , sexual minorities and sex workers require additional protections as they are more vulnerable to privacy, confidentiality, stigma, discrimination, and exploitation issues during a research study.

Research proposals should ensure the dignity of these participants is protected and that they have access to quality healthcare.

Investigators should consult the community, if possible, prior to the proposal being finalized. Tribal Populations. The G-ICMR states that research on tribal populations should only be conducted if it is of a specific therapeutic, diagnostic, and preventative nature with appropriate benefits to the tribal population. The tribal leader, or other culturally appropriate authority may serve as the gatekeeper from whom permission to enter and interact should be obtained.

Additional precautions should be taken to avoid including children, pregnant women, and elderly people belonging to particularly vulnerable tribal groups. Benefit sharing with the tribal group should also be ensured for any research done using tribal knowledge that may have the potential for commercialization. Persons in Subordinate or Dependent Groups. As indicated in the G-ICMR , while reviewing protocols involving participants who are engaged in subordinate or dependent relationships, the EC must ensure the following:.

Terminally Ill Patients. Per the G-ICMR , terminally ill patients or patients seeking new treatments are vulnerable as they are ready to give consent for any intervention that could help them. The EC should carefully review protocols and recruitment procedures for these studies and comply with the following requirements:. As per the G-ICMR , children are individuals who have not obtained the legal age of consent, which is As stated in the G-ICMR , the CTRules , and the G-Children , in the case of pediatric clinical trials, the participants are legally unable to provide written informed consent, and are dependent on their legal representative s or guardian s to assume responsibility for their participation in a research study.

In these studies, the following requirements should be complied with:. The CTRules further specifies requirements for pediatric studies involving new drugs.

These studies must take into account the following issues:. The reviewing ethics committee EC should also include members who are knowledgeable about pediatric, ethical, clinical, and psychosocial issues.

Refer to the CTRules for detailed pediatric study requirements. The EC should consider the circumstances of the children to be enrolled in the study including their age, health status, and other factors and potential benefits to other children with the same disease or condition, or to society as a whole.

In addition, the G-Children should be consulted for detailed EC assessment criteria to be used to evaluate research studies involving children.

Assent Requirements. Per the CTRules , mature minors and adolescents should personally sign and date a separately designed written assent form. For children between seven 7 and 11 years, oral assent must be obtained in the presence of their legal representative s or guardian s.

For children between 12 and 18 years, written assent must be obtained. The EC may also issue a waiver of assent in the following circumstances:.

For details and guidance on preparing and using an assent form, see the G-Children. As per the CTRules and the G-ICMR , clinical studies involving pregnant or nursing women and fetuses require additional safeguards to ensure that the research assesses the risks to the women and the fetuses.

The following conditions are required for research to be conducted involving pregnant or nursing women or fetuses. Per the CTRules :. Fetuses and Neonates. As described in the G-Children , study protocols involving neonates should take into consideration that this group is the most vulnerable within the pediatric population in terms of the risk of long-term effects of interventions, including developmental effects.

ECs should scrutinize all proposed research for potential risks and weigh them against the possible benefits, and ensure a competent person s conducts a proper scientific review of the protocol. In addition, when possible, older children should be studied before conducting studies in younger children and infants.

The consent of one 1 parent is also required for neonate studies where research exposes them to no or minimal risk, or in studies that offer the prospect of direct benefit to the participant.

However, for studies that do not offer the prospect of direct benefit or are high-risk, consent from both parents is required.

Exceptions to this requirement include the following:. If both parents are minors, then enrollment of such a baby should be avoided as much as possible. Investigator s should provide adequate justification to the EC to enroll such neonates for research. A legally acceptable representative should provide an informed consent in such situations. As noted in the G-ICMR , prisoners are included in the description of vulnerable populations due to their diminished autonomy caused by dependency or being under a hierarchical system.

The G-ICMR also states that the presence of a mental disorder is not synonymous with incapacity of understanding or inability to provide informed consent. ECs should exercise caution and require researchers to justify exceptions and their need to depart from the guidelines governing research. ECs should ensure that these exceptions are as minimal as possible and are clearly spelled out in the informed consent form.

As delineated in the CTRules , an investigational product IP is defined as the pharmaceutical formulation of an active ingredient or a placebo including the comparator product being tested or used as a reference in a clinical trial. The CTRules further defines an investigational new drug as a new chemical or biological entity or a product having a therapeutic indication, but which has never been tested before on human participants.

The DCGI approves the manufacture or import of IPs as part of the clinical trial application review and approval process. After reviewing the information and documents accompanying the application in Form CT, the DCGI will, if satisfied, grant permission to manufacture the IP by providing Form CT within 90 working days from the date of application receipt.

If dissatisfied, the DCGI will reject the application, for reasons to be recorded in writing, within a period of 90 working days from the date the application was submitted. In the case where the DCGI indicates there are some deficiencies in the application that may be rectified, the applicant must be informed of these deficiencies within a period of 90 working days.

If the applicant chooses to rectify the deficiencies within the specified period and provide the required information and documents, the DCGI must review the application again, and if satisfied, grant manufacturing permission to the applicant. If still dissatisfied, the DCGI will reject the application within a period of 90 working days from the date the required information and documents were provided. In the case of rejection, the applicant may request the DCGI reconsider the application within a period of 60 working days from the rejection date along with payment of the specified fees in the CTRules and submission of the required information and documents.

Refer to the CTRules for additional timeline information. Applicants who intend to manufacture an unapproved active pharmaceutical ingredient API to develop a pharmaceutical formulation for clinical trial purposes should submit to the DCGI either Form CT, if applying as a pharmaceutical formulation manufacturer, or Form CT, if applying as an API manufacturer.

These forms are available in the CTRules. After reviewing the information and documents accompanying the application in Form CT or CT, and conducting further inquiry, if any is required, the DCGI will grant permission to the applicant to manufacture the unapproved API in Form CT and permission to the manufacturer of the pharmaceutical formulation in Form CT within 90 working days. Refer to Notice18Feb20 for additional information. Per Notice13Mar20 , when the application is solely to conduct a clinical trial, the DCGI also requires the sponsor to submit the international non-proprietary name INN or generic name, drug category, dosage form and data supporting IP stability in the intended container-closure system for the duration of the clinical trial see the CTRules Second Schedule, Table 1 for detailed data requirements.

If approved, the DCGI will grant permission for a period of three 3 years to both manufacturers of new drugs or investigational new drugs and manufacturers of unapproved APIs. In exceptional circumstances, the DCGI may extend the period of permission for an additional year.

Once approved, the import license must remain valid for three 3 years from the date of its issue, unless suspended or cancelled. In exceptional circumstances, the DCGI may extend the license for an additional year. See also IND for a checklist of manufacturing and import related forms to be included in a global clinical trial application submission.

According to the CTRules , the sponsor must submit a fee of 5, Indian National Rupees INRs per product with an application for permission to manufacture or import the IP to be used in a clinical trial.

As explained in IND , the DCGI does not require a drug import license to be obtained when an ethics committee EC has granted approval for the conduct of an academic clinical trial that will be using a permitted drug formulation with a new indication, a new route of administration, a new dose, or a new dosage form.

A copy of the EC approval for the trial must be provided to the Port office at the time of import along with a letter of undertaking that specifies the quantity of the drug being imported and states that it will be used exclusively for the academic clinical trial. As per the CTRules , for new drugs already approved outside India, the results of local clinical trials may not be necessary to submit along with the application to import or manufacture a new drug if the DCGI decides to grant permission on the basis of data available from countries to be specified in a future DCGI order.

See Regulatory Authority topic, Scope of Assessment subtopic for detailed waiver requirements. This decision will vary depending on the specific clinical trial phase proposed and the clinical parameters related to the study drug. The CTRules requires the IB to contain the version number, release date, and the following sections:. Refer to the CTRules for detailed content guidelines. See the Investigational Products topic, Product Management subtopic for additional information on IP supply, storage, and handling requirements.

Additionally, per Notice13Mar20 , when the application is solely to conduct a clinical trial, the DCGI also requires the sponsor to submit the international non-proprietary name INN or generic name, drug category, dosage form and data supporting IP stability in the intended container-closure system for the duration of the clinical trial see the CTRules Second Schedule, Table 1 for detailed data requirements.

As noted in the CTRules the applicant is required to provide the following:. In addition, the CTRules and IND explain that the DCGI will consider a local clinical trial waiver for approval of a new drug already approved in other countries if the following conditions are met:. Per the CTRules and IND , the labeling of any new drug or investigational new drug manufactured or imported for the purpose of conducting a clinical trial or for testing and analysis should include the following items:.

According to the CTRules and IND , in the event that a new drug or investigational new drug manufactured for clinical trial or testing and analysis purposes is left over, remains unused, incurs damage, has an expired shelf life date, or has been found to be of sub-standard quality, the drug must be destroyed and the action taken should be recorded. The CTRules also describes investigational product IP management requirements in the context of proposed protocol contents to be submitted as part of the clinical trial application submission.

Note: The regulatory sources provide overlapping and unique elements so each of the items listed above will not necessarily be in each source.

The G-XBiolMat definition also includes the following:. As per the G-XBiolMat , these biological specimens or human material samples may be obtained from the following sources:. In the case of international research collaboration involving human biological material transfer, the G-XBiolMat and the G-ICMR indicate that the export of all biological materials is to be covered under existing GOI and ethics guidelines.

The exchange of human biological material from and to WHO Collaborating Centres for specific purposes, as well as for individual cases of diagnosis or therapeutic purposes, may not require permission. However, Indian participating center s must have appropriate regulatory approval and registration to receive foreign funds for research.

For more information, see the HumBiol-ImprtExprt. In addition, per the G-ICMR , it is necessary for all health research involving human participants and their biological material and data to be reviewed and approved by an appropriately constituted ethics committee EC. In addition to the informed consent form ICF required elements listed in the Informed Consent topic , the G-ICMR require investigator s to communicate the following information to participants in the ICF regarding the use of their biological samples:.

The GCLP further indicates that prior to specimen collection, appropriate counseling should be completed and written consent obtained. Human Genetic Research Consent Requirements. As stated in the G-ICMR , investigator s must comply with stringent norms and exercise caution in conducting the consent process with participants for genetic research purposes.

The following considerations must be taken into account during this process:. However, even if group consent is taken, it will not be a replacement for individual consent. In addition, as indicated in the G-ICMR , the transfer of human biological material to be stored at a biorepository or a biobank, or another institution, must be communicated to the participant.

Please refer to Section 11 of the G-ICMR for detailed consent requirements associated with storing human biological materials in a biorepository or a biobank.

See the Informed Consent topic, Required Elements and Participant Rights subtopics for additional information on informed consent. Details on the most recent India updates are available here. We would welcome your feedback on ClinRegs. Please consider taking 2 minutes to complete a brief survey.

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The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own.

Trials registered in CTRI will be monitored to ensure increasing voluntary disclosure of all items in the register. These items have been selected in order to:. Improve transparency and accountability 3 : By disclosing all required details of the protocol of trials, public confidence in clinical trials is likely to be enhanced. Improve the internal validity of trials : Empirical research has shown that some aspect of the methods of the trial are particularly important to produce reliable results by minimizing biases, confounders and the effects of chance or coincidence.

These include the method of random sequence generation, adequate concealment of allocation of participants to interventions, adequate blinding of participants, investigators and outcome assessors, and inclusion of all participants' results 4, 5. The CTRI hopes that these items, though not mandatory at present, will be disclosed by all registrants, as incorporating such elements at the protocol stage is likely to increase the internal validity of the trial and also increase the chances of publication in a high impact journal that endorses the ICMJE requirement of reporting trials in accordance with the CONSORT statement 6, 7.

Conform to accepted ethical standards : The Indian Council of Medical Research through its Bio-ethics initiative has developed ethical guidelines for the conduct of trials and for ethics committees 8. Clearance by local ethics committees is mandatory for all clinical trials and the CTRI hopes that making disclosure of ethical clearance a mandatory field for registration, it will lead to better links with the ICMR's bio-ethics initiative. Health Condition of trial participants is now coded as per ICD classification and must be chosen from the drop down list provided up to a maximum of 4 levels to the nearest disease category possible.

About CTRI Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based.