India combines large patient populations, experienced investigators and cost-effective sites with a detailed regulatory framework for consent and safety. Capture runs Indian sites in the same study with verified eConsent signatures and a complete audit trail.
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Study region
India
Key points for studies in India
Consent
After public concern about trial practices in the early 2010s, India strengthened its rules on informed consent, compensation for trial-related injury and ethics oversight. Consent must be in a language the participant understands, and in certain trials the consent process must also be audio-visually recorded and the recording retained.
Electronic consent helps with the written part: Capture records the participant's on-screen signature, verified with a one-time email code, the investigator's countersignature with password re-authentication, and optional impartial witness and legally authorised representative signatures. Each signature is linked to the exact document signed, and the signed PDF exports with the audit trail. Where audio-visual recording is required, sites follow their own recording procedure alongside it.
Multi-state Indian studies often need consent and questionnaires in Hindi and several regional languages. Plan translations early, use official translations of validated instruments, and track which version each participant signed.
Meaning of signature
I have reviewed this adverse event and confirm the assessment of seriousness, severity and causality.
Signer
Dr. A. Ozola, PI
Password
••••••••••
Safety reporting
Indian rules set strict timelines for reporting serious adverse events and for assessing compensation. In Capture, a serious event raises a routed safety alert straight away, the SAE timeline tracks it from site awareness, and investigator sign-off is recorded under an electronic signature.
SAE timeline
SAE reported
Day 0 · 09:12
Safety alert acknowledged
Medical monitor · 09:40
Site staff attestation
Study coordinator · 11:05
AE sign-off (PI / Sub-I)
Awaiting signature
Sign a test consent and report a test SAE in the free sandbox.
Before you start
Under the New Drugs and Clinical Trials Rules, 2019.
For each site.
Before the first participant is enrolled.
Languages, audio-visual recording where required, and impartial witness arrangements.
Arrangements for trial-related injury in place.
DPDP Act obligations and transfer basis documented.
Participant protections
The New Drugs and Clinical Trials Rules require the sponsor to provide free medical management to a participant who suffers an injury during the trial, for as long as required, and financial compensation where the injury or death is related to the trial. Ethics committees and the licensing authority review these cases, and the rules set timelines for reporting and for decisions.
For the data system, this means serious adverse events need complete information quickly: onset, seriousness criteria, causality assessment, treatment given and outcome. Recording those consistently on the AE log, with the SAE timeline tracked from site awareness and investigator sign-off under an electronic signature, gives the sponsor and ethics committee what they need to assess each case.
Consent
| Element | What to plan |
|---|---|
| Language | Consent in a language the participant understands; approved translations per site. |
| Audio-visual recording | Required in certain trials; site recording procedure and secure storage. |
| Impartial witness | For participants who cannot read; witness signature captured with the consent. |
| Legally acceptable representative | For participants who cannot consent themselves. |
| Compensation information | Medical management and compensation explained in the consent. |
| Version control | Each participant's signed version recorded and retrievable. |
Capture captures impartial witness and legally authorised representative signatures alongside the participant's and investigator's.
CDSCO, headed by the Drugs Controller General of India, under the New Drugs and Clinical Trials Rules, 2019.
Yes. Trials must be registered in the Clinical Trials Registry – India (CTRI) before enrolment.
Audio-visual recording of the consent process is required in certain trials, for example those involving vulnerable participants. Sites follow their recording procedure alongside the written or electronic consent.
Capture hosts study data in the EU (Frankfurt) or the US (N. Virginia), chosen at study setup, with AES-256 encryption at rest and TLS in transit. Assess the cross-border transfer rules that apply to your study before choosing.
Yes. The free sandbox has every feature with no credit card and no time limit.
Keep exploring
eConsent software
Verified electronic consent.
Adverse event reporting
SAE timelines.
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Another large-population guide.
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Multi-site clinical trial management
Sites across states and countries.
IRB and ethics committees
Ethics review explained.
Verified eConsent and SAE tracking. Free sandbox.