Registration of observational studies is voluntary

In any BA/BE study, if after check-in of volunteer in study and before drug administration (during housing), a volunteer reports any medical, should it be reported as AE?

In general, if a subject experiences an event, such as an inter current illness or condition (e.g., infection, headache, rise in blood pressure) after the subject agreed to participate in the study, signed the IRB-approved informed consent form, and passed the screening tests but before administration of any study drug, this event should not be reported as an AE/SAE

As the subject has not yet received study drug in the scenario you describe, the event could not be considered associated with the use of the study drug. However, because such an event such could affect the subject's eligibility/continued eligibility for the study, the event should still be recorded by the study site in the study records, tracked, and be reported to the sponsor.

What is implied by the new order of ancillary care dated 3rd July 2014? Is this linked to compensation rule?

The new order is not related to compensation or SAE management .The order clearly says that there should be provision for providing ancillary care to patients suffering from any other illness during the trial.

We have almost completed 50% of an observational study, which is registered on CTRI. Will these kinds of studies be registered with Clinicaltrials.gov? Will this additional registration benefit the study?
Registration of observational studies is voluntary and the observational study type (see study type data element on ClinicalTrials.gov) can be used to register studies of human beings in which biomedical and/or health outcomes are assessed in predefined groups of individuals, but the investigator does not assign specific interventions to the study participants. This will provide access to the Observational Study Design data elements on ClinicalTrials.gov, including observational study model, time perspective, and biospecimen information.

The patient registry observational study subtype (see study type data element on ClinicalTrials.gov) can be used to indicate that an observational study is also considered to be a patient registry. The Agency for Healthcare Research and Quality (AHRQ) defines a patient registry as including an organized system that uses observational methods to collect uniform data (clinical and other) prospectively for a population defined by a particular disorder/disease, condition (including susceptibility to a disorder), or exposure (including products, health care services, or procedures) and that serves a predetermined scientific, clinical, or policy purpose. Patient registries may be single-purpose or ongoing data collection programs that address one or more questions. Additional information about patient registries is available at AHRQ's registry of patient registries.

Observational study records should be updated and maintained in the same manner as interventional study records.

If you have registered the study on CTRI, there is no additional benefit of registration on Clintrials.gov. However, you can register the study at any time in clintrials.gov. Only in case of clinical trial, FDA Amendments Act (FDAAA 801) requires the trial to be registered within 21 days of enrollment of the first participant.

One of the most important need for registration of any study is to comply with ICMJE requirement for publication of the study. International Committee of Medical Journal Editors (ICMJE) and other journals require registration of clinical trials prior to enrollment of the first participant.